Total 16 job vacancies by ModernaTX, Inc.

The Role:

Moderna is seeking a Director of Epidemiology, Early HEOR & Patient-Centered Outcomes Assessment (Epi, & PCOA) to support the strategy, design and implementation of evidence generation activities activities targeted towards supporting the regulatory approval and reimbursement

 of Moderna’s Rare Disease mRNA technologies within its Therapeutics portfolio at the global level. The candidate has responsibility, under the supervision of the Epi Director, who is the Program Lead for various Rare Disease to lead one of these indications.  This includes the design, development, conduct, analysis, reporting and publication of pharmacoepidemiologic research studies, PCOA measurement and development strategy (where warranted), plan and execute the early reimbursement/HEOR activities and provide epidemiologic and methodologic input towards the clinical development needs of mRNA technologies.

Specifically, the candidate will support and/or lead as appropriate, activities focusing on generating observational evidence to support mRNA technologies (early and late stage) associated with Inborn Errors of Metabolism. The role will report to the Director, Epidemiology Lead. The successful candidate is driven, curious, collaborative, with a bold ambition to contribute to ground-breaking drug development with potential to transform multiple diseases with very high unmet medical need. 

The candidate must have excellent oral and written communication skills, innovative approaches, a willingness to learn new concepts and a collaborative mindset. As this is a global role, the candidate may be called upon to work across different time zones at times. The candidate will be charged with understanding the observational data needs and opportunities to enhance drug development with the mRNA platform, and build expertise as needed within the Rare Disease portfolio.

Here’s What You’ll Do:

Epidemiology:

• Under the guidance and strategic leadership of the Senior Epi/ PCOA lead, accountable for the development and execution of the overall Epi/PCOA strategy for Propionic Acidemia (PA) and other future indications as determined by the needs of the portfolio.

• Provide Epi input to the product development, including clinical, safety, and economic outcomes and contribute to the integrated evidence plans for PA

• Design and execute pre-launch, launch and post-marketing epidemiology/real world evidence plans, as needed

• Responsible to support the strategy, vision and execution of high-quality pharmacoepidemiologic data outputs, for PA including:

  • Develop protocols, data analysis plans, study reports and peer-reviewed publications.

  • Conduct Literature reviews and gap analyses for safety, effectiveness, and impact studies.

  • Conduct studies from conceptualization, through publication of descriptive, cohort, cross-sectional, or observational studies or registries

  • Design and input into clinical trial or external control studies to ensure value-drivers for provider/patient/payer evidence needs from launch through LOE are included

• Provide epidemiologic analysis, literature reviews, or literature-based indirect treatment comparisons to fill knowledge gaps and inform (data contextualization, event rates, population descriptors, etc)

• Active leader and team member providing strategic input in terms of observational data and strategy to the development team in collaboration with cross-functional partners on the clinical development plan, regulatory interactions, clinical study design, efficacy and safety endpoints

• Support mRNA development by strategic contribution to the assessment of need for use of observational data, evaluation of data sources, design and conduct of observational studies for RD needs and/or developing mRNA technologies 

• With guidance and direction from Indication Epi Lead, serve as a cross functional partner for HTA advice & building of economic models at global level

• Provide epidemiologic support to other RD Moderna therapeutics programs as needed

• Preferred: Analytical skills and technical knowledge of registries/real world data studies; general understanding of global (US, EU) payer and market access evidentiary needs and reimbursement environment and the processes associated with reimbursement and formulary access to enable input into CDP and other evidence generation needs

Real World Evidence & Early HEOR:

• Identify evidence gaps and needs from regulatory and reimbursement perspectives, resolve these challenges and define evidence generation priorities to support payers and regulators

• Leading early payer scientific advice with global stakeholders including strategic insights on PROs, economic models and trial design

• Defining and delivering the RWE and early HEOR strategy to support specified assets, and leading the integrated evidence teams to execute the activities needed for advancing assets through to launch

• Provide innovative solutions on RWE for use as a synthetic/historical or concurrent control, including expertise on methodological considerations to account for confounding, missing variable, temporal or other biases and/or methodological challenges which may need to be thought through, including alternative methodological approaches (Bayesian, Adaptive, etc)

• Develop research methodologies and implement innovative analytical approaches for Epi & RWE

• Develop protocols for RWD analysis of claims data or electronic health records and execution of RWE studies to identify and fill gaps and ensure delivery of robust evidence alongside clinical development and value-based RWE needs

• Proactively prepare for mRNA use and exposure by establishing epidemiological and RWE on the key disease, population, demographic and clinical variables

• Lead RWE publications for congresses and peer-reviewed journals

• Develop and maintain strong, collaborative relationships with the broader Moderna organization and with external experts

Patient-Centered Outcomes Assessment (PCOA):

• Support PCOA, including the development, validation (or adaptation) and creation of Clinical Outcome Assessments (COA) and psychometric measurement strategy 

• Select & incorporate COA endpoints and implement strategy and input into COA measurement section protocols and CDP and to develop briefing documents in support of and attend regulatory interactions as the Moderna subject matter expert

Here’s What You’ll Bring to the Table:

• PhD in Epidemiology, Pharmacoepidemiology or Health Economics strongly preferred and MPH/MS in Epidemiology in combination with other advanced degrees considered. Preference given to candidates with previous experience in drug development

• Minimum 5-7 years’ experience in an industry setting, preferably in a related therapeutic area and at least 8-10 years experience in consultancy supporting RWE/HEOR type activities

• Proven track record in:

  • Planning and execution of Epidemiology/RWE and HEOR Plans to enhance value and accelerate development

  • Deliver high-quality results within established timelines

  • Lead cross-functional teams and work streams

  • Ability to interact with local and or regional stakeholders

  • Innovation in trial design including leveraging synthetic controls and real-world data

• Ability to thrive and multi-task in a fast-paced environment is ESSENTIAL

• Attention to detail, internal drive to generate high-quality work, and sense of passion and urgency to achieve team and program goals

• Excellent analytical, problem-solving and strategic planning skills

• Strong interpersonal skills commensurate with the need to work closely with CROs, investigators, consultants, and team members across functions

• Exceptional written and oral communication skills to meet the needs of varied audiences

Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:

• Highly competitive and inclusive medical, dental and vision coverage options
• Flexible Spending Accounts for medical expenses and dependent care expenses
• Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
• Family care benefits, including subsidized back-up care options and on-demand tutoring
• Free premium access to fitness, nutrition, and mindfulness classes 
• Exclusive preferred pricing on Peloton fitness equipment
• Adoption and family-planning benefits
• Dedicated care coordination support for our LGBTQ+ community
• Generous paid time off, including:
  •    Vacation, sick time and holidays
  •    Volunteer time to participate within your community
  •    Discretionary year-end shutdown
  •    Paid sabbatical after 5 years; every 3 years thereafter
• Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
• 401k match and Financial Planning tools
• Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
• Complimentary concierge service including home services research, travel booking, and entertainment requests
• Free parking or subsidized commuter passes
• Location-specific perks and extras!

About Moderna

Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. 

By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.

We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.

If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.

Moderna is a smoke-free, alcohol-free and drug-free work environment.

Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!

Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.

Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We’re focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.

Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Talent Acquisition Partner or contact the Accommodations team at leavesandaccommodations@modernatx.com.  (EEO/AAP Employer) 

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The Role:

Moderna is seeking a Director of Clinical Operations to manage Oncology programs which may consist of one or more studies. This position will be responsible for initiating and leading clinical programs, inclusive of studies, across all phases, including overseeing CROs and vendors and working cross-functionally on clinical operations strategy and related initiatives. This position reports to the Executive Director, Clinical Operations, Oncology. This position will work collaboratively across the Oncology and cross-functional teams on the overall development programs and related studies to ensure successful execution of assigned projects.

Here’s What You’ll Do:

• Accountable for delivery of assigned clinical program/studies budget, timelines, and resource management with focus on quality, including making recommendations and decisions regarding operational strategies to support study and/or program objectives

• Develop operational strategy and clinical operations plans in support of execution of the Clinical Development Plan

• Partner and collaborate with cross-functional stakeholders such as the Project Leader, Clinical Development Lead, Regulatory Lead, and other relevant stakeholders

• Lead and oversee execution of first-in-human through phase 4 trials, depending on lifecycle of program, in compliance with ICH/GCP, local regulations, and Moderna SOPs

• Support the selection, oversight, and management of CROs and other vendors

• Oversee site feasibility/capability assessments in collaboration with the CRO and cross-functional team

• Review and provide clinical operations input into relevant clinical documents such as the protocol, investigator brochure, regulatory documents, clinical study reports and other documents and plans as appropriate

• Manage and provide oversight to the cross functional team and CRO/vendor(s) related to all aspects of clinical trial operations

• Responsible for representing Clinical Operations on cross-functional project teams and vendor/CRO operational meetings and ensuring compliance with operational standards and procedures.

• Along with other Clinical Development personnel, represent Moderna externally to Investigators, site staff, and Key Opinion Leaders

• Perform and document study level Sponsor Oversight of outsourced clinical activities

• Communicate study-status, cost and issues to ensure timely decision-making by senior management

• Oversee/collaborate on and contribute to inspection readiness activities that support audits and regulatory inspections related to clinical trial conduct

• Maintain oversight and participate in the creation/review/training/maintenance of departmental and organizational SOPs to ensure compliance

• Lead and/or participate in clinical operations workstreams related to departmental and operating model related initiatives

• Develop and foster strong, collaborative relationships with key stakeholders both within and external to Moderna

• Support program level deliverables/activities

• Provide oversight and mentorship to assigned Clinical Trial Managers and Clinical Trial Associates by providing clinical operations and functional area expertise and support identification and prioritization of study and program level work. May include direct line management of Clinical Operations staff.

• Strive for continuous improvement and more efficient ways of working in clinical development

• Act as a role model for Moderna’s values

Here’s What You’ll Bring to the Table:

• Minimum of BA/BS with at least 10 years of trial and clinical program experience, including 6+ years of high complexity independent, global trial management experience and 2+ years of program-level management Advanced degree preferred.

• Experience in Immuno-Oncology is required. Experience in both solid tumors and hematologic malignancies is desirable. A mixture of early and late stage experience is desirable, some early development experience is required.

• Robust experience in early and late phase drug development

• Multi-dimensional Clinical Operations background with capability of devising plans for operational challenges such as site activation, subject enrollment, monitoring oversight, protocol deviation management, data cleaning, etc.

• Cross-Collaboration proficiency with other therapeutic areas and functions such as Regulatory, CMC, Biostatistics, Data Management, Finance, Program Management, etc.

• Experience in GCP inspections/audits

• Outstanding verbal and written communication skills, in addition to excellent organizational skills

• Proven track record of effective leadership and team-building skills in the context of a multi-disciplinary team in the biotech or pharmaceutical industry

• Resilient, Creative, capable problem-solver

• Excellent organizational skills and ability to work independently

• Experience in establishing and maintaining relationships with key opinion leaders

• Some travel required

Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:

• Highly competitive and inclusive medical, dental and vision coverage options
• Flexible Spending Accounts for medical expenses and dependent care expenses
• Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
• Family care benefits, including subsidized back-up care options and on-demand tutoring
• Free premium access to fitness, nutrition, and mindfulness classes 
• Exclusive preferred pricing on Peloton fitness equipment
• Adoption and family-planning benefits
• Dedicated care coordination support for our LGBTQ+ community
• Generous paid time off, including:
  •    Vacation, sick time and holidays
  •    Volunteer time to participate within your community
  •    Discretionary year-end shutdown
  •    Paid sabbatical after 5 years; every 3 years thereafter
• Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
• 401k match and Financial Planning tools
• Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
• Complimentary concierge service including home services research, travel booking, and entertainment requests
• Free parking or subsidized commuter passes
• Location-specific perks and extras!

About Moderna

Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. 

By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.

We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.

If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.

Moderna is a smoke-free, alcohol-free and drug-free work environment.

Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!

Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.

Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We’re focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.

Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Talent Acquisition Partner or contact the Accommodations team at leavesandaccommodations@modernatx.com.  (EEO/AAP Employer) 

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The Role:

Reporting to the Director, CDO Business Analytics & Operations Management, the Associate Director, CDO Clinical Financial Planning will collaborate cross-functionally on the development and implementation of cost management tools and processes within Clinical Development Operations (CDO). The ideal candidate will bring experience in analyzing and reporting clinical trial financial data, with a primary focus on clinical trial costing, scenario planning, and exploring trial optionality.

This role is pivotal in rapidly driving financial decision making and requires a candidate who is highly analytical, detail-oriented, and has a knack for transforming complex data into actionable insights. The successful candidate will have a proven ability to communicate complex financial information to diverse teams and stakeholders, and to collaborate effectively across the organization.

This position will also play a key role in clinical study financial risk management and process improvement. They are expected to identify and advise study teams on financial risks and impact to budget, continuously enhance study financial planning processes, ensure compliance with standards and internal processes and procedures, and provide training and guidance on financial planning related to clinical trials.

Here’s What You’ll Do:

• Ensure accuracy of clinical trial budgets and forecasting, including modeling clinical study spend and supporting or developing system to support cost models with related assumptions

• Develop, implement, and support financial planning tools and models focused on costing clinical trials and identifying cost-efficient options

• Facilitate predictive analytics related to the cost of clinical trials, enabling rapid decision-making and efficiency

• Collaborate with key stakeholders to transform business questions and data into cost-effective solutions for clinical trials

• Lead initiatives and projects related to Clinical Financial Planning, ensuring solutions are scalable and follow best practices

• Deliver accurate, innovative, and timely insights (ex. creation of dashboards and monthly reports providing transparency into clinical trial costs and trends)

• Collaborate with CDO functions and R&D Finance to establish best practices, processes, and training for the financial planning of clinical trials

• Provide subject matter expertise to teams on financial planning, budgeting, and forecasting related to clinical trials

• Support teams in generating data around costing to allow for a financial assessment and impact for new studies, programs, and/or amendments to existing studies

• Identify potential financial risks for clinical trials and propose mitigation strategies

• Continuously evaluate and improve the planning process and systems used within role to increase efficiency and accuracy

• Provide input as needed to financial aspects of contracts and agreements with third party vendors providing services on clinical trials

• Liaise between R&D finance and CDO to ensure alignment and understanding of financial data on clinical trials

Here’s What You’ll Bring to the Table:

• BA/BS required, advanced degree preferred

• Minimum of 10+ years of experience in a clinical research environment within the pharmaceutical, CRO and biotech industry

• Minimum of 7+ years of direct experience in clinical trial financial planning, reporting, and analysis

• Proficiency in financial modeling and forecasting, with a strong understanding of financial systems and databases

• Experience with ClearTrial or similar software/tools preferred

• Excellent analytical and critical thinking skills, with a demonstrated ability to transform complex data into actionable insights

• Record of establishing effective business relationships with internal and external customers, demonstrating strong collaboration skills, commitment to relationship building, and a relentless focus on delivering on commitments

• Ability to collaborate effectively in a dynamic, cross-functional matrix environment

• Effective communication skills, with the ability to explain complex financial information to non-financial stakeholders

Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:

• Highly competitive and inclusive medical, dental and vision coverage options
• Flexible Spending Accounts for medical expenses and dependent care expenses
• Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
• Family care benefits, including subsidized back-up care options and on-demand tutoring
• Free premium access to fitness, nutrition, and mindfulness classes 
• Exclusive preferred pricing on Peloton fitness equipment
• Adoption and family-planning benefits
• Dedicated care coordination support for our LGBTQ+ community
• Generous paid time off, including:
  •    Vacation, sick time and holidays
  •    Volunteer time to participate within your community
  •    Discretionary year-end shutdown
  •    Paid sabbatical after 5 years; every 3 years thereafter
• Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
• 401k match and Financial Planning tools
• Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
• Complimentary concierge service including home services research, travel booking, and entertainment requests
• Free parking or subsidized commuter passes
• Location-specific perks and extras!

About Moderna

Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. 

By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.

We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.

If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.

Moderna is a smoke-free, alcohol-free and drug-free work environment.

Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!

Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.

Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We’re focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.

Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Talent Acquisition Partner or contact the Accommodations team at leavesandaccommodations@modernatx.com.  (EEO/AAP Employer) 

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The Role:

Moderna is seeking an Associate Director of Clinical Operations to manage rare disease studies. This consist of more than one study. This position will be responsible for initiating and leading clinical studies, across all phases, including overseeing CROs and vendors and working cross-functionally on clinical operations strategy and related initiatives. This position reports to the Senior Director, Clinical Operations within Therapeutics. This position will work collaboratively across the rare disease and cross-functional teams on the overall development programs and related studies to ensure successful execution of assigned projects. This position may also oversee studies in other therapeutic areas within the TA, including oncology studies.

Here’s What You’ll Do:

• Accountable for delivery of assigned clinical studies budget, timelines, and resource management with focus on quality, including making recommendations and decisions regarding operational strategies to support study and/or program objectives

• Develop operational strategy and clinical operations plans in support of execution of the Clinical Development Plan

• Partner and collaborate with cross-functional stakeholders such as the Project Leader, Clinical Development Lead, Regulatory Lead, and other relevant stakeholders

• Lead and oversee execution of first-in-human through phase 4 trials, depending on lifecycle of program, in compliance with ICH/GCP, local regulations, and Moderna SOPs

• Support the selection, oversight, and management of CROs and other vendors

• Oversee site feasibility/capability assessments in collaboration with the CRO and cross-functional team

• Review and provide clinical operations input into relevant clinical documents such as the protocol, investigator brochure, regulatory documents, clinical study reports and other documents and plans as appropriate

• Manage and provide oversight to the cross functional team and CRO/vendor(s) related to all aspects of clinical trial operations

• Responsible for representing Clinical Operations on cross-functional project teams and vendor/CRO operational meetings and ensuring compliance with operational standards and procedures.

• Along with other Clinical Development personnel, represent Moderna externally to Investigators, site staff, and Key Opinion Leaders

• Perform and document study level Sponsor Oversight of outsourced clinical activities

• Communicate study-status, cost and issues to ensure timely decision-making by senior management

• Oversee/collaborate on and contribute to inspection readiness activities that support audits and regulatory inspections related to clinical trial conduct

• Maintain oversight and participate in the creation/review/training/maintenance of departmental and organizational SOPs to ensure compliance

• Lead and/or participate in clinical operations workstreams related to departmental and operating model related initiatives

• Develop and foster strong, collaborative relationships with key stakeholders both within and external to Moderna

• Support program level deliverables/activities

• Provide oversight and mentorship to assigned Clinical Trial Managers and Clinical Trial Associates by providing clinical operations and functional area expertise and support identification and prioritization of study and program level work.

• Strive for continuous improvement and more efficient ways of working in clinical development

• Act as a role model for Moderna’s values

Here’s What You’ll Bring to the Table:

• Minimum of BA/BS with at least 8-10 years of trial and clinical program experience, including 4+ years of high complexity independent, global trial management experience. Clinical program management experience of 1-2 years is desirable.

• Experience in oncology is required; experience rare disease is desirable.

• Robust experience in early and late phase drug development

• Multi-dimensional Clinical Operations background with capability of devising plans for operational challenges such as site activation, subject enrollment, monitoring oversight, protocol deviation management, data cleaning, etc.

• Cross-Collaboration proficiency with other therapeutic areas and functions such as Regulatory, CMC, Biostatistics, Data Management, Finance, Program Management, etc.

• Experience in GCP inspections/audits

• Outstanding verbal and written communication skills, in addition to excellent organizational skills

• Proven track record of effective leadership and team-building skills in the context of a multi-disciplinary team in the biotech or pharmaceutical industry

• Resilient, Creative, capable problem-solver

• Excellent organizational skills and ability to work independently

• Experience in establishing and maintaining relationships with key opinion leaders

• Some travel required

Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:

• Highly competitive and inclusive medical, dental and vision coverage options
• Flexible Spending Accounts for medical expenses and dependent care expenses
• Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
• Family care benefits, including subsidized back-up care options and on-demand tutoring
• Free premium access to fitness, nutrition, and mindfulness classes 
• Exclusive preferred pricing on Peloton fitness equipment
• Adoption and family-planning benefits
• Dedicated care coordination support for our LGBTQ+ community
• Generous paid time off, including:
  •    Vacation, sick time and holidays
  •    Volunteer time to participate within your community
  •    Discretionary year-end shutdown
  •    Paid sabbatical after 5 years; every 3 years thereafter
• Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
• 401k match and Financial Planning tools
• Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
• Complimentary concierge service including home services research, travel booking, and entertainment requests
• Free parking or subsidized commuter passes
• Location-specific perks and extras!

About Moderna

Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. 

By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.

We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.

If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.

Moderna is a smoke-free, alcohol-free and drug-free work environment.

Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!

Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.

Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We’re focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.

Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Talent Acquisition Partner or contact the Accommodations team at leavesandaccommodations@modernatx.com.  (EEO/AAP Employer) 

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The Role:

Reporting to the Director, CDO Business Analytics & Operations Management, the Associate Director, CDO Clinical Financial Planning will collaborate cross-functionally on the development and implementation of cost management tools and processes within Clinical Development Operations (CDO). The ideal candidate will bring experience in analyzing and reporting clinical trial financial data, with a primary focus on clinical trial costing, scenario planning, and exploring trial optionality.

This role is pivotal in rapidly driving financial decision making and requires a candidate who is highly analytical, detail-oriented, and has a knack for transforming complex data into actionable insights. The successful candidate will have a proven ability to communicate complex financial information to diverse teams and stakeholders, and to collaborate effectively across the organization.

This position will also play a key role in clinical study financial risk management and process improvement. They are expected to identify and advise study teams on financial risks and impact to budget, continuously enhance study financial planning processes, ensure compliance with standards and internal processes and procedures, and provide training and guidance on financial planning related to clinical trials.

Here’s What You’ll Do:

• Ensure accuracy of clinical trial budgets and forecasting, including modeling clinical study spend and supporting or developing system to support cost models with related assumptions

• Develop, implement, and support financial planning tools and models focused on costing clinical trials and identifying cost-efficient options

• Facilitate predictive analytics related to the cost of clinical trials, enabling rapid decision-making and efficiency

• Collaborate with key stakeholders to transform business questions and data into cost-effective solutions for clinical trials

• Lead initiatives and projects related to Clinical Financial Planning, ensuring solutions are scalable and follow best practices

• Deliver accurate, innovative, and timely insights (ex. creation of dashboards and monthly reports providing transparency into clinical trial costs and trends)

• Collaborate with CDO functions and R&D Finance to establish best practices, processes, and training for the financial planning of clinical trials

• Provide subject matter expertise to teams on financial planning, budgeting, and forecasting related to clinical trials

• Support teams in generating data around costing to allow for a financial assessment and impact for new studies, programs, and/or amendments to existing studies

• Identify potential financial risks for clinical trials and propose mitigation strategies

• Continuously evaluate and improve the planning process and systems used within role to increase efficiency and accuracy

• Provide input as needed to financial aspects of contracts and agreements with third party vendors providing services on clinical trials

• Liaise between R&D finance and CDO to ensure alignment and understanding of financial data on clinical trials

Here’s What You’ll Bring to the Table:

• BA/BS required, advanced degree preferred

• Minimum of 10+ years of experience in a clinical research environment within the pharmaceutical, CRO and biotech industry

• Minimum of 7+ years of direct experience in clinical trial financial planning, reporting, and analysis

• Proficiency in financial modeling and forecasting, with a strong understanding of financial systems and databases

• Experience with ClearTrial or similar software/tools preferred

• Excellent analytical and critical thinking skills, with a demonstrated ability to transform complex data into actionable insights

• Record of establishing effective business relationships with internal and external customers, demonstrating strong collaboration skills, commitment to relationship building, and a relentless focus on delivering on commitments

• Ability to collaborate effectively in a dynamic, cross-functional matrix environment

• Effective communication skills, with the ability to explain complex financial information to non-financial stakeholders

Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:

• Highly competitive and inclusive medical, dental and vision coverage options
• Flexible Spending Accounts for medical expenses and dependent care expenses
• Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
• Family care benefits, including subsidized back-up care options and on-demand tutoring
• Free premium access to fitness, nutrition, and mindfulness classes 
• Exclusive preferred pricing on Peloton fitness equipment
• Adoption and family-planning benefits
• Dedicated care coordination support for our LGBTQ+ community
• Generous paid time off, including:
  •    Vacation, sick time and holidays
  •    Volunteer time to participate within your community
  •    Discretionary year-end shutdown
  •    Paid sabbatical after 5 years; every 3 years thereafter
• Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
• 401k match and Financial Planning tools
• Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
• Complimentary concierge service including home services research, travel booking, and entertainment requests
• Free parking or subsidized commuter passes
• Location-specific perks and extras!

About Moderna

Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. 

By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.

We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.

If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.

Moderna is a smoke-free, alcohol-free and drug-free work environment.

Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!

Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.

Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We’re focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.

Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Talent Acquisition Partner or contact the Accommodations team at leavesandaccommodations@modernatx.com.  (EEO/AAP Employer) 

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The Role:

Reporting to the Director, CDO Business Analytics & Operations Management, the Associate Director, CDO Clinical Financial Planning will collaborate cross-functionally on the development and implementation of cost management tools and processes within Clinical Development Operations (CDO). The ideal candidate will bring experience in analyzing and reporting clinical trial financial data, with a primary focus on clinical trial costing, scenario planning, and exploring trial optionality.

This role is pivotal in rapidly driving financial decision making and requires a candidate who is highly analytical, detail-oriented, and has a knack for transforming complex data into actionable insights. The successful candidate will have a proven ability to communicate complex financial information to diverse teams and stakeholders, and to collaborate effectively across the organization.

This position will also play a key role in clinical study financial risk management and process improvement. They are expected to identify and advise study teams on financial risks and impact to budget, continuously enhance study financial planning processes, ensure compliance with standards and internal processes and procedures, and provide training and guidance on financial planning related to clinical trials.

Here’s What You’ll Do:

• Ensure accuracy of clinical trial budgets and forecasting, including modeling clinical study spend and supporting or developing system to support cost models with related assumptions

• Develop, implement, and support financial planning tools and models focused on costing clinical trials and identifying cost-efficient options

• Facilitate predictive analytics related to the cost of clinical trials, enabling rapid decision-making and efficiency

• Collaborate with key stakeholders to transform business questions and data into cost-effective solutions for clinical trials

• Lead initiatives and projects related to Clinical Financial Planning, ensuring solutions are scalable and follow best practices

• Deliver accurate, innovative, and timely insights (ex. creation of dashboards and monthly reports providing transparency into clinical trial costs and trends)

• Collaborate with CDO functions and R&D Finance to establish best practices, processes, and training for the financial planning of clinical trials

• Provide subject matter expertise to teams on financial planning, budgeting, and forecasting related to clinical trials

• Support teams in generating data around costing to allow for a financial assessment and impact for new studies, programs, and/or amendments to existing studies

• Identify potential financial risks for clinical trials and propose mitigation strategies

• Continuously evaluate and improve the planning process and systems used within role to increase efficiency and accuracy

• Provide input as needed to financial aspects of contracts and agreements with third party vendors providing services on clinical trials

• Liaise between R&D finance and CDO to ensure alignment and understanding of financial data on clinical trials

Here’s What You’ll Bring to the Table:

• BA/BS required, advanced degree preferred

• Minimum of 10+ years of experience in a clinical research environment within the pharmaceutical, CRO and biotech industry

• Minimum of 7+ years of direct experience in clinical trial financial planning, reporting, and analysis

• Proficiency in financial modeling and forecasting, with a strong understanding of financial systems and databases

• Experience with ClearTrial or similar software/tools preferred

• Excellent analytical and critical thinking skills, with a demonstrated ability to transform complex data into actionable insights

• Record of establishing effective business relationships with internal and external customers, demonstrating strong collaboration skills, commitment to relationship building, and a relentless focus on delivering on commitments

• Ability to collaborate effectively in a dynamic, cross-functional matrix environment

• Effective communication skills, with the ability to explain complex financial information to non-financial stakeholders

Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:

• Highly competitive and inclusive medical, dental and vision coverage options
• Flexible Spending Accounts for medical expenses and dependent care expenses
• Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
• Family care benefits, including subsidized back-up care options and on-demand tutoring
• Free premium access to fitness, nutrition, and mindfulness classes 
• Exclusive preferred pricing on Peloton fitness equipment
• Adoption and family-planning benefits
• Dedicated care coordination support for our LGBTQ+ community
• Generous paid time off, including:
  •    Vacation, sick time and holidays
  •    Volunteer time to participate within your community
  •    Discretionary year-end shutdown
  •    Paid sabbatical after 5 years; every 3 years thereafter
• Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
• 401k match and Financial Planning tools
• Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
• Complimentary concierge service including home services research, travel booking, and entertainment requests
• Free parking or subsidized commuter passes
• Location-specific perks and extras!

About Moderna

Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. 

By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.

We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.

If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.

Moderna is a smoke-free, alcohol-free and drug-free work environment.

Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!

Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.

Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We’re focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.

Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Talent Acquisition Partner or contact the Accommodations team at leavesandaccommodations@modernatx.com.  (EEO/AAP Employer) 

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The Role:

Reporting directly to the Senior Director or Executive Director of Medical Writing, this pivotal role carries the significant responsibility of ensuring the delivery of high-quality clinical and regulatory writing. From meticulous planning and coordination to delivering the final drafts, the role demands a keen eye for detail and a robust understanding of the clinical development landscape. This individual will form an integral part of Moderna’s clinical development team, working closely with them to understand and contribute to the broader objectives of Moderna’s clinical development program. This is not just a job, it's an opportunity to drive change and make a difference in the world of biotechnology.

Here’s What You’ll Do:

• Functional Knowledge: Demonstrate a comprehensive understanding of concepts and principles for overseeing the managing medical writing and regulatory writing across multiple clinical development programs.

• Document Planning & Project Management: Oversee the planning, writing, and reviewing of clinical and regulatory documents and responses.

• Cross-Functional Collaboration: Work closely with cross-functional teams to ensure timely delivery of high-quality documents.

• Regulatory Compliance: Ensure all documents comply with regulatory guidelines.

• Data Interpretation: Interpret clinical and statistical data to prepare clear, concise documents.

• Quality Control: Implement and oversee quality control processes for medical writing.

• Document Updates: Manage the updates and revisions of documents as required.

• Problem Solving: Direct the resolution of highly complex or unusual business problems applying advanced critical thinking.

• Impact: Guided by functional plans, impact the quality and timeliness of the functional area and results, and develop area plans.

• Develop and Implement Departmental Strategies: Set goals and objectives for the medical writing team that align with the company's overall strategy.

• Line Management: Oversee and manage the performance of a high-performing medical writing team, providing guidance, feedback, and mentorship. Responsible for hiring, training, and professional development of team members. Ensure resources are allocated effectively and deadlines are met consistently. Foster a collaborative and positive team environment.

Here’s What You’ll Bring to the Table:

• Education: Advanced degree (preferred) with a minimum of 10 years of relevant experience OR bachelors degree with a minimum of 15 years of relevant experience.

• Industry Experience: Proven experience in clinical development, regulatory affairs, or medical affairs.

• Interpersonal Skills: Ability to influence others internally and/or externally, including colleagues in other departments. Some negotiation with limited impact may be required.

• Leadership Skills: Ability to lead dynamically through senior managers or professionals. Translate and execute functional business strategy across multiple related disciplines and contribute to strategic planning for medical writing.

• Business Expertise: Apply market knowledge to drive integrated results across multiple related teams.

• Communication Skills: Excellent written and oral communication skills.

• Quality: Commitment to quality, ensuring that all work produced meets the highest standards of accuracy and comprehensiveness. High attention to detail, organizational skills, and the ability to manage multiple tasks simultaneously.

• Technical Skills: Proficiency in MS Office and familiarity with medical writing software.

Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:

• Highly competitive and inclusive medical, dental and vision coverage options
• Flexible Spending Accounts for medical expenses and dependent care expenses
• Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
• Family care benefits, including subsidized back-up care options and on-demand tutoring
• Free premium access to fitness, nutrition, and mindfulness classes 
• Exclusive preferred pricing on Peloton fitness equipment
• Adoption and family-planning benefits
• Dedicated care coordination support for our LGBTQ+ community
• Generous paid time off, including:
  •    Vacation, sick time and holidays
  •    Volunteer time to participate within your community
  •    Discretionary year-end shutdown
  •    Paid sabbatical after 5 years; every 3 years thereafter
• Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
• 401k match and Financial Planning tools
• Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
• Complimentary concierge service including home services research, travel booking, and entertainment requests
• Free parking or subsidized commuter passes
• Location-specific perks and extras!

About Moderna

Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. 

By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.

We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.

If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.

Moderna is a smoke-free, alcohol-free and drug-free work environment.

Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!

Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.

Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We’re focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.

Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Talent Acquisition Partner or contact the Accommodations team at leavesandaccommodations@modernatx.com.  (EEO/AAP Employer) 

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The Role

In this Associate Director role, you will be responsible for translating our Technical Development strategy into execution. The Technical Development organization is comprised of scientists, engineers, and problem solvers that develop and implement the most innovative, advanced, and robust platform manufacturing processes and analytical technologies to deliver Moderna’s medicines. In this highly cross-functional role, you will collaborate within the Technical Development organization and beyond, including GMP Operations, Supply Chain, Finance, HR, CMC Portfolio Operations, and R&D. The role is based in Moderna’s new Moderna Technology Center campus in Norwood, MA.

The role requires a master integrator gifted in bringing together people, technical concepts, and business goals with best-in-class execution. You thrive in a fast-paced environment and are comfortable rolling up your sleeves – if a process doesn’t exist yet, you define it. You are comfortable applying program and project management principles to ensure cross-functional teams are well informed, organized and primed to execute. People applaud your ability to deliver in real (and often high stakes) situations. You can digest new technical concepts and leverage this understanding to develop a strong collaborative relationship with technical peers.

Here’s What You’ll Do

• Drive the day-to-day execution of Technical Development strategy with clear communication, prioritization, and escalation, both within program-specific Technical Development Teams (TDTs) and other operating groups

• Oversee the management of critical cross-functional projects within the Technical Development portfolio by providing both project management and business process expertise.

• Lead team meetings and ensure that clear agendas are set, actions and decisions are documented, communicated and committed to, enabling timeline achievement.

• Develop tools and framework for comparison and selection of timeline and technical scenarios.

• Enhance, create and maintain tools, workflows and business processes to keep information flowing within TDTs.

• Build strong working relationships across departments, with key stakeholders to ensure transparency and to facilitate communication.

• Collaboratively develop and maintain interactive dashboards from the data gathered, providing trackable metrics and regular readouts on program/project progress

• Right-size processes borne from rapid growth, bringing them to scale.

• Continue to build and maintain the Technical Development culture and community.

• Additional duties as may be assigned from time to time.

Here’s What You’ll Need (Basic Qualifications)

• Education: B.S. degree in life sciences, chemistry, engineering or equivalent

• Experience: 10+ years in the life sciences, biotech, pharmaceutical or similar industry

• Proficient in project management software: Smartsheet, MS Project or similar.

• Proficient in collaboration tools such MS Teams, SharePoint, Miro

Here’s What You’ll Bring to the Table (Preferred Qualifications)

• Understanding of the biopharmaceutical development lifecycle from R&D through commercialization, including an understanding of the interdependencies of work done in various functional groups (such as Process and Analytical Development).

• Previous experience with supporting regulatory filings (IND or BLA).

• Ability to apply project management/integration tools and principles.

• Outstanding communication skills and ability to operate effectively in ambiguity by anticipating and balancing needs of multiple stakeholders.

• Exceptional skills at facilitating teams and building consensus with membership comprised of diverse levels and areas of the company.

• Working knowledge or awareness of data visualization tools such as Tableau, PowerBI, SmartSheet or similar

• A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative

Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:

• Highly competitive and inclusive medical, dental and vision coverage options
• Flexible Spending Accounts for medical expenses and dependent care expenses
• Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
• Family care benefits, including subsidized back-up care options and on-demand tutoring
• Free premium access to fitness, nutrition, and mindfulness classes 
• Exclusive preferred pricing on Peloton fitness equipment
• Adoption and family-planning benefits
• Dedicated care coordination support for our LGBTQ+ community
• Generous paid time off, including:
  •    Vacation, sick time and holidays
  •    Volunteer time to participate within your community
  •    Discretionary year-end shutdown
  •    Paid sabbatical after 5 years; every 3 years thereafter
• Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
• 401k match and Financial Planning tools
• Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
• Complimentary concierge service including home services research, travel booking, and entertainment requests
• Free parking or subsidized commuter passes
• Location-specific perks and extras!

About Moderna

Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. 

By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.

We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.

If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.

Moderna is a smoke-free, alcohol-free and drug-free work environment.

Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!

Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.

Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We’re focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.

Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Talent Acquisition Partner or contact the Accommodations team at leavesandaccommodations@modernatx.com.  (EEO/AAP Employer) 

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The Role:

This role is an exciting opportunity to be a critical part of the talent engine fueling a high growth organization that is radically changing the biotech industry. The Lead Human Resources Business Partner – Corporate Functions will be responsible for establishing and maintaining effective relationships with one or more Sr Leaders in our Corporate Functions and their respective teams while also driving the efficient and effective delivery of key Human Resources projects and objectives.  Success in this role will draw from an established track record of successfully partnering with functional leaders to build capability and maintain effective teams, leading through Moderna’s values and Mindsets, all while delivering results. This role is a key member of the Corporate Function HRBP team and reports to the HR Executive Partner for Corporate Functions. The HRBP team is focused on being a Moderna culture ambassador, business enablement, delivering against intense people growth objectives of the company while also promoting a high-performance culture.

The Lead HR Business Partner will work collaboratively with the Human Resources team and other subject matter experts to solution and align practices and initiatives with the Company’s strategic and operational goals.

Here’s What You’ll Do:

• Provide strategic counsel to key functions and management in the areas of organizational effectiveness and development, coaching and talent management.

• Engage cross-functionally and assist staff at many levels in optimizing the performance of their teams and resolving issues.

• Contribute to creating solutions in such areas as employment, employee communication, talent and career development, employee relations, compensation, benefits, and HRIS delivery.

• Support continued growth and infrastructure by helping to identify talent gaps and development areas across the Corporate Functions and other areas as the business grows.

• Focus on relentless ability to build/re-build teams by using strong capability planning/workforce planning experience to diagnose and recommend best-fit org design frameworks.

• Provide day-to-day support to employees and managers regarding HR practices, HRIS systems, employee relations, development etc.

• Ensure system workflows and communication are efficiently executed across key functions.

• Support HR Executive Partner on key projects and initiatives as well as day-to-day tasks.

Here’s What You’ll Bring to the Table:

Basic Qualifications:

• Bachelor's degree and 10+ years progressive Human Resources Business Partnership experience required.

• Experience leading enterprise-wide initiatives in a fast growth environment is required, including skill in partnering with other members of the HR team.

• Proven experience leading and owning capability/workforce planning and re-org work in a dynamic, evolving environment.

Preferred Qualifications:

• Proven HR business partnership experience within the Finance/Corporate Functions

• Prior experience working in a dynamic global technology, biotechnology and/or pharmaceutical organization.

• Ability to form strong partnerships and trust with employees regardless of level.

• Ability to prioritize and manage multiple projects and collaborate effectively in a dynamic, cross-functional matrix environment.

• Ability to flex and demonstrate dynamic range in managing both strategic and tactical role responsibilities.

• Proven track record of assessing and selecting high potential talent for both their subject matter expertise and cultural fit.

• Experience and comfort in working with EC & VP level business leaders and in helping them tackle business and talent issue.

• Demonstrated ability to influence & represent ideas through development of compelling business cases.

• Outstanding communication skills (verbal and written).

• A natural ability to be organized in how you think, communicate, and conduct your work.

• A desire to be part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.

• Strong proficiency in Power Point, Excel, and Workday.

Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:

• Highly competitive and inclusive medical, dental and vision coverage options
• Flexible Spending Accounts for medical expenses and dependent care expenses
• Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
• Family care benefits, including subsidized back-up care options and on-demand tutoring
• Free premium access to fitness, nutrition, and mindfulness classes 
• Exclusive preferred pricing on Peloton fitness equipment
• Adoption and family-planning benefits
• Dedicated care coordination support for our LGBTQ+ community
• Generous paid time off, including:
  •    Vacation, sick time and holidays
  •    Volunteer time to participate within your community
  •    Discretionary year-end shutdown
  •    Paid sabbatical after 5 years; every 3 years thereafter
• Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
• 401k match and Financial Planning tools
• Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
• Complimentary concierge service including home services research, travel booking, and entertainment requests
• Free parking or subsidized commuter passes
• Location-specific perks and extras!

About Moderna

Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. 

By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.

We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.

If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.

Moderna is a smoke-free, alcohol-free and drug-free work environment.

Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!

Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.

Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We’re focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.

Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Talent Acquisition Partner or contact the Accommodations team at leavesandaccommodations@modernatx.com.  (EEO/AAP Employer) 

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The Role:

We are seeking a talented and experienced Director to lead our in vivo pharmacology research team. The successful candidate will play an integral role across our oncology research groups, overseeing the development of relevant in vivo animal and cell models, and the design and execution of pharmacology studies to propel our pre-clinical research and early development oncology pipeline in addition to Translational initiatives, such as in vivo combination evaluations. The Director will manage all internal and/ or external in vivo workflows, collaborating with various teams within Moderna, including Cancer Vaccine Research, Immuno-Oncology Research, and Research Operations. The ideal candidate will be a proven and effective team leader and people manager, highly collaborative team player, possess excellent communication skills, have a proven track record of independent research achievements, and bring innovative approaches to further our mission.

Here’s What You’ll do:

• Direct the execution and analysis of in vivo pharmacology studies that support oncology programs and platform initiatives

• Develop and refine in vivo murine tumor models and study protocols, ensuring compliance with regulatory, ethical, and quality standards; including serving as Principal Investigator on internal in vivo pharmacology protocols

• Identify new tumor models and new techniques that will further advance mRNA therapies

• Work closely with internal teams to optimize in vivo study designs and oversee their execution, whether conducted in-house or through external partners

• Establish and maintain partnerships with Contract Research Organizations (CROs), industry partners and academic institutions for all in vivo studies

• Manage the analysis, review, and summary of in vivo pharmacology data to ensure robustness as well as integration into big picture considerations

• Contribute to and co-author scientific reports for inclusion in regulatory submissions, internal and external presentations

• Lead and allocate team resources and timelines to ensure the efficient progression of studies and achievement of objectives across multiple programs and oncology-focused teams

Here’s What You’ll Bring to the Table:

• Advanced degree in Pharmacology, Oncology, or a related scientific field, with a PhD or DVM and at least 9+ years relevant experience

• Demonstrated expertise in in vivo pharmacology within oncology drug discovery and early development, preferably with a focus on nucleic acid therapeutics and vaccines

• Deep knowledge of immuno-oncology including current and emerging standards of care to inform forward translational studies

• Experienced in the creation and use of diverse in vivo cancer models for efficacy and PK/PD studies, including advanced local, systemic, disseminated, and orthotopic syngeneic, xenograft and genetically engineered murine models

• Knowledge in overseeing relevant cell model development to be deployed in vivo

• Highly experienced in in vivo study management, including pharmacological agent administration via IV, IP, SC, iTu, IM, and PO dosing routes including vaccination protocols; regular health and tumor growth monitoring; bioluminescence/fluorescence imaging using IVIS systems; necropsy and tissue collections

• Experienced in authoring, implementing and ensuring compliance to study protocols under IACUC guidelines

• Ability to mentor and develop junior scientists and research associates, and guide teams to successfully conduct in vivo studies, trouble shoot, and grow technically and scientifically

• Skilled in outsourcing studies and fostering productive relationships with CROs and/or academic collaborators

Additional Preferred Qualifications:

• Experience with cell line engineering, humanized models, or surgical/ resection models  

• Familiarity with regulatory guidelines and Good Laboratory Practice (GLP) standards

• Experience with bioinformatics tools relevant to pharmacology and oncology research

•  Facility with data analysis software tools such as GraphPad Prism

• Exceptional organizational abilities, attention to detail, scientific adaptability, and a results-driven approach

• Superior written and verbal communication skills, with the capacity to effectively engage with multiple teams

• A respectful, inclusive, and collaborative mindset, complemented by boldness, creativity, curiosity, and relentlessness

Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:

• Highly competitive and inclusive medical, dental and vision coverage options
• Flexible Spending Accounts for medical expenses and dependent care expenses
• Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
• Family care benefits, including subsidized back-up care options and on-demand tutoring
• Free premium access to fitness, nutrition, and mindfulness classes 
• Exclusive preferred pricing on Peloton fitness equipment
• Adoption and family-planning benefits
• Dedicated care coordination support for our LGBTQ+ community
• Generous paid time off, including:
  •    Vacation, sick time and holidays
  •    Volunteer time to participate within your community
  •    Discretionary year-end shutdown
  •    Paid sabbatical after 5 years; every 3 years thereafter
• Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
• 401k match and Financial Planning tools
• Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
• Complimentary concierge service including home services research, travel booking, and entertainment requests
• Free parking or subsidized commuter passes
• Location-specific perks and extras!

About Moderna

Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. 

By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.

We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.

If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.

Moderna is a smoke-free, alcohol-free and drug-free work environment.

Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!

Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.

Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We’re focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.

Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Talent Acquisition Partner or contact the Accommodations team at leavesandaccommodations@modernatx.com.  (EEO/AAP Employer) 

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Reporting to CSO, External Research Ventures of Moderna, the Senior Director (SD) of Pulmonary Research is responsible for overseeing our therapeutic pulmonary research projects as well as leading and managing our external pulmonary research collaborations.  The SD of Pulmonary Research will be responsible for building our internal pulmonary capabilities and expertise, overseeing mRNA drug discovery projects into preclinical development, and driving the strategy for this emerging therapeutic area.  The SD will work closely with multiple internal stakeholders across functions including Platform, Nonclinical Sciences, Translational, Clinical Development, and R&D Strategy in addition to key external stakeholders involved in our external collaborations.  This is a superb opportunity for a highly motivated leader with pulmonary drug discovery expertise to join our dynamic team and impact our early pipeline.

Here’s What You’ll Do:

• Build and establish internal pulmonary capabilities and expertise to enable the inhaled pulmonary modality and therapeutics area
• Lead and direct a range of internal pulmonary therapeutic research projects.  Define objectives for research projects and ensure high-quality execution of these projects, including oversight of assays, study designs, and data
• Advance pulmonary therapeutic research projects into early development
• Oversee and manage relationships with external partners and collaborators.  Serve as Program Lead for external collaboration, effectively managing a large cross-functional internal team and working closely with external stakeholders to scientifically direct collaborations
• Mentor and have direct management responsibilities for the pulmonary research team
• Stay up-to-date with the latest scientific advances in pulmonary research and identify opportunities to incorporate new research methods and technologies
• Promote cross-functional collaboration across the organization
• Effectively communicate research progress, challenges and results to a variety of stakeholders, including teams across R&D organizations

Here’s What You’ll Bring to the Table:

• Ph.D. in pulmonary pharmacology, respiratory medicine, or related field with 12 years of relevant experience in pulmonary research in industry setting
• Strong pulmonary physiology and pharmacology experience
• Excellent leadership and team building skills.
• Strong track record driving discovery projects into early development and leading successful research teams and projects
• Proven ability to oversee and manage strategic partnerships and collaborations.
• Deep understanding of the scientific aspects of drug discovery and development
• Excellent leadership and team building skills.
• Strong written and oral communication skills scaling through all levels of the organization, including senior management.
• Strong leadership skills and an ability to collaborate productively across multiple cross-functional project teams are paramount.
• Ability to thrive in a fast-paced environment; ability to adapt to changes with demonstrated flexibility to pivot as warranted and needed.
• Acts with urgency with the understanding that actions today compound lives saved tomorrow.
• Acts like an owner, obsesses over learning, questions convention, and strives to push past possible.
• Scientific rigor & commitment to excellence and innovation.

Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:

• Highly competitive and inclusive medical, dental and vision coverage options
• Flexible Spending Accounts for medical expenses and dependent care expenses
• Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
• Family care benefits, including subsidized back-up care options and on-demand tutoring
• Free premium access to fitness, nutrition, and mindfulness classes 
• Exclusive preferred pricing on Peloton fitness equipment
• Adoption and family-planning benefits
• Dedicated care coordination support for our LGBTQ+ community
• Generous paid time off, including:
  •    Vacation, sick time and holidays
  •    Volunteer time to participate within your community
  •    Discretionary year-end shutdown
  •    Paid sabbatical after 5 years; every 3 years thereafter
• Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
• 401k match and Financial Planning tools
• Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
• Complimentary concierge service including home services research, travel booking, and entertainment requests
• Free parking or subsidized commuter passes
• Location-specific perks and extras!

About Moderna

Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. 

By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.

We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.

If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.

Moderna is a smoke-free, alcohol-free and drug-free work environment.

Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!

Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.

Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We’re focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.

Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Talent Acquisition Partner or contact the Accommodations team at leavesandaccommodations@modernatx.com.  (EEO/AAP Employer) 

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The Role:

We are seeking a talented, motivated and proven scientific leader to expand our capabilities and capacity for mass spectrometry (MS) and immunopeptidomic work flows across discovery and pre-clinical Cancer Vaccine Research (CVR) initiatives.  The successful candidate will be a technical expert and recognized leader in the MS/immunopeptidomics field ideally with experience in the discovery and pre-clinical development of novel medicines for cancer patients, and at minimum, an interest in being an essential partner to our CVR discovery, preclinical development and platform objectives.   A strong background in immunology, proteomics, and cancer vaccines in addition to the successful leadership of a research team in regard to scientific, technical, strategic and people management are essential to help us maximize the impact we will have on cancer patients. 

Here's What You’ll Do:

• Lead, manage and expand the MS and immunopeptidomic analysis workflows in the context of cancer vaccine research, including sample preparation, LC-MS/MS analysis, and data interpretation; for target discovery and validation, as well as related efforts to further characterize and optimize our cancer vaccine platform.

• Build internal and leverage external resources to ensure utilization and leverage of cutting edge technologies and processes.

• Develop and implement new methods and technologies to enhance immunopeptidomic analysis capabilities for the discovery and validation of tumor-associated antigens and neoantigens.

• Collaborate with the Computational Sciences team to analyze and interpret immunopeptidomic data, and integrate it with genomic and transcriptomic data to guide the design of cancer vaccines.

• Provide scientific leadership and guidance to team members, fostering an environment of innovation and excellence.

• Collaborate with other research teams to integrate immunopeptidomic data with other research areas, such as immune monitoring and vaccine efficacy studies.

• Contribute to the writing and reviewing of scientific manuscripts, grants, and patents related to cancer vaccine research.

• Present findings at internal meetings and international conferences.

• Ensure compliance with all applicable regulations and maintain up-to-date knowledge of literature in the field of cancer vaccines and immunopeptidomics.

• Serve as further nucleus and leader in our across company MS Working team (including individuals in Protein Sciences, Infectious Disease Research, Technical Development and Immune Therapeutics Discovery).

Here’s What You’ll Bring to the Table:

• PhD in Immunology, Biochemistry, Molecular Biology, or a related field.

• A minimum of 9 years of postdoctoral experience in immunopeptidomic analyses related to cancer vaccine discovery, validation and early development.

• Extensive experience with LC-MS/MS and related proteomic technologies, including in depth knowledge of state-of-the-art equipment from Bruker and Thermo Fisher.

• Proficiency in bioinformatics tools and software used in immunopeptidomic analysis.

• Strong track record of team and project leadership, and scientific publications in the field of cancer vaccines and/or immunopeptidomics.

• Excellent leadership, communication, collaboration and project management skills.

• Ability to work in a fast-paced, dynamic, team-oriented environment working on multiple projects with aggressive timelines.

Preferred Qualifications:

• Experience with antigen presentation and T cell biology and related assays beyond MS/immunopeptidomics in the context of cancer immunotherapy.

• Experience with other omics technologies, such as genomics and transcriptomics, in relation to cancer vaccine research.

Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:

• Highly competitive and inclusive medical, dental and vision coverage options
• Flexible Spending Accounts for medical expenses and dependent care expenses
• Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
• Family care benefits, including subsidized back-up care options and on-demand tutoring
• Free premium access to fitness, nutrition, and mindfulness classes 
• Exclusive preferred pricing on Peloton fitness equipment
• Adoption and family-planning benefits
• Dedicated care coordination support for our LGBTQ+ community
• Generous paid time off, including:
  •    Vacation, sick time and holidays
  •    Volunteer time to participate within your community
  •    Discretionary year-end shutdown
  •    Paid sabbatical after 5 years; every 3 years thereafter
• Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
• 401k match and Financial Planning tools
• Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
• Complimentary concierge service including home services research, travel booking, and entertainment requests
• Free parking or subsidized commuter passes
• Location-specific perks and extras!

About Moderna

Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. 

By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.

We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.

If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.

Moderna is a smoke-free, alcohol-free and drug-free work environment.

Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!

Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.

Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We’re focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.

Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Talent Acquisition Partner or contact the Accommodations team at leavesandaccommodations@modernatx.com.  (EEO/AAP Employer) 

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The Role:

Moderna is seeking a Director of Clinical Operations to manage rare disease programs which may consist of one or more studies. This is a clinical operations program management role.  This position will be responsible for initiating and leading clinical programs, across all phases, including overseeing CROs and vendors and working cross-functionally on clinical operations strategy and related initiatives. This position reports to the Senior Director, Clinical Operations, Therapeutics with a focus on Rare Disease. This position will work collaboratively across the rare disease and cross-functional teams on the overall development programs and related studies to ensure successful execution of assigned projects. This position may also work on other programs, including oncology or emerging areas such as autoimmune or cardiovascular.

Here’s What You’ll Do:

• Accountable for delivery of assigned clinical program budget, timelines, and resource management with focus on quality, including making recommendations and decisions regarding operational strategies to support study and/or program objectives

• Develop operational strategy and clinical operations plans in support of execution of the Clinical Development Plan

• Partner and collaborate with cross-functional stakeholders such as the Project Leader, Clinical Development Lead, Regulatory Lead, and other relevant stakeholders

• Oversee execution of first-in-human through phase 4 trials, depending on lifecycle of program, in compliance with ICH/GCP, local regulations, and Moderna SOPs

• Support the selection, oversight, and management of CROs and other vendors

• Oversee site feasibility/capability assessments in collaboration with the CRO and cross-functional team

• Review and provide clinical operations input into relevant clinical documents such as the protocol, investigator brochure, regulatory documents, clinical study reports and other documents and plans as appropriate

• Manage and provide oversight to the cross functional team and CRO/vendor(s) related to all aspects of clinical trial operations

• Responsible for representing Clinical Operations on cross-functional project teams and vendor/CRO operational meetings and ensuring compliance with operational standards and procedures.

• Along with other Clinical Development personnel, represent Moderna externally to Investigators, site staff, and Key Opinion Leaders

• Perform and document study level Sponsor Oversight of outsourced clinical activities

• Communicate study-status, cost and issues to ensure timely decision-making by senior management

• Oversee/collaborate on and contribute to inspection readiness activities that support audits and regulatory inspections related to clinical trial conduct

• Maintain oversight and participate in the creation/review/training/maintenance of departmental and organizational SOPs to ensure compliance

• Lead and/or participate in clinical operations workstreams related to departmental and operating model related initiatives

• Develop and foster strong, collaborative relationships with key stakeholders both within and external to Moderna

• Support program level deliverables/activities

• Provide oversight and mentorship to assigned Clinical Trial Managers and Clinical Trial Associates by providing clinical operations and functional area expertise and support identification and prioritization of study and program level work. May include direct line management of Clinical Operations staff.

• Strive for continuous improvement and more efficient ways of working in clinical development

• Act as a role model for Moderna’s values

Here’s What You’ll Bring to the Table:

• Minimum of BA/BS with at least 10 years of trial and clinical program experience, including 6+ years of high complexity independent, global trial management experience and 2+ years of program-level management Advanced degree preferred.

• Experience in oncology is required. Experience in rare disease and other complex therapeutic areas is highly desirable.

• Robust experience in early and late phase drug development

• Multi-dimensional Clinical Operations background with capability of devising plans for operational challenges such as site activation, subject enrollment, monitoring oversight, protocol deviation management, data cleaning, etc.

• Cross-Collaboration proficiency with other therapeutic areas and functions such as Regulatory, CMC, Biostatistics, Data Management, Finance, Program Management, etc.

• Experience in GCP inspections/audits

• Outstanding verbal and written communication skills, in addition to excellent organizational skills

• Proven track record of effective leadership and team-building skills in the context of a multi-disciplinary team in the biotech or pharmaceutical industry

• Resilient, Creative, capable problem-solver

• Excellent organizational skills and ability to work independently

• Experience in establishing and maintaining relationships with key opinion leaders

• Some travel required

Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:

• Highly competitive and inclusive medical, dental and vision coverage options
• Flexible Spending Accounts for medical expenses and dependent care expenses
• Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
• Family care benefits, including subsidized back-up care options and on-demand tutoring
• Free premium access to fitness, nutrition, and mindfulness classes 
• Exclusive preferred pricing on Peloton fitness equipment
• Adoption and family-planning benefits
• Dedicated care coordination support for our LGBTQ+ community
• Generous paid time off, including:
  •    Vacation, sick time and holidays
  •    Volunteer time to participate within your community
  •    Discretionary year-end shutdown
  •    Paid sabbatical after 5 years; every 3 years thereafter
• Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
• 401k match and Financial Planning tools
• Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
• Complimentary concierge service including home services research, travel booking, and entertainment requests
• Free parking or subsidized commuter passes
• Location-specific perks and extras!

About Moderna

Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. 

By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.

We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.

If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.

Moderna is a smoke-free, alcohol-free and drug-free work environment.

Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!

Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.

Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We’re focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.

Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Talent Acquisition Partner or contact the Accommodations team at leavesandaccommodations@modernatx.com.  (EEO/AAP Employer) 

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The Role:

Reporting to the SVP Facilities and Engineering, based at our Norwood, MA site,

the Senior Director of Global Engineering is a technical leadership position at the organization, one which has primary responsibility for leading the conceptual and detailed engineering of new manufacturing and R&D facilities worldwide. The candidate will lead a group of subject matters experts across multiple disciplines including Plasmid, mRNA Drug Substance, mRNA Drug Product Manufacturing, Plant and Clean Utilities including HVAC. The position requires broad engineering knowledge of the Drug Substance and Drug Product Manufacturing Technologies. It also requires strong project management skills with the ability to keep multiple projects on their timelines and on budgets in a fast based and demanding environment. Candidate must have a strong process approach and an eye toward continuous improvement with as are strong organizational skills and written and verbal communication skills.
 

Candidate should have knowledge of regulatory and performance requirements for pharmaceutical manufacturing facilities. Candidate will establish and lead a local team of project delivery and manufacturing support resources (Process Engineering for Drug Substance and Drug product Manufacturing, Plant and GMP Utilities) at remote locations for project execution. Candidate would be responsible for overall project delivery up to Operational Readiness milestone.

Travel to support global manufacturing expansion could be up to 25% at critical project phases.

Here’s What You Will Do:

• Partners with the Capital Project Delivery and Project Control Team in the delivery of manufacturing, Office, and R&D facilities worldwide.

• Lead combines technical team of mRNA Drug Substance process engineer, facilities and utilities engineers, process improvement, Sterile Filling, Automatic Inspection and Packaging, on capital projects delivery in compliance with regulatory standards.

• Ensure good engineering practices are followed through for the performance of control and coordination activities on all process phases (planning, development, approval, and implementation); integration and synergies between Global and local requirements; ensure maintenance and operations best practices and guidelines sharing across Moderna’s mfg. network

• Strategic and tactical leadership of design, construction, commissioning, qualification (if applicable) and operational readiness workstreams for capital project portfolio.

• Partner with MS&T (Manufacturing Sciences & Technology) (Manufacturing Sciences & Technology) and Technical Development organizations in the development of novel manufacturing technologies around Moderna’s mRNA platform.

• Provide input to short- and long-term capital planning

• Own and drive energy reduction program for the site through conservation, new equipment, and technologies to reduce overall costs and drive sustainability

• Working closely with procurement, direct the bid evaluation and contract award processes and coordinate the negotiation of contracts with engineering firms, process equipment vendors, skid, and oversight of equipment acquisition activities

• Provide leadership in the management of external design team professionals from project inception through completion and ensure they produce thorough and accurate drawings which comply with all established standards

• Ensure review of all construction drawing documents and specifications, coordinating necessary reviews with business unit representatives and regulatory authorities

• Coordinate with internal stakeholders to insure efficient and timely turnover of space for effective operations, including a maintenance and calibration package

• Oversee relationship with the local municipality authorities for project permitting and other business related to site improvements

• Recruit and hire top engineering talent

• Grow and mentor process engineering teams at manufacturing sites

• Work with the Engineering leadership to scale the engineering organization as required by Moderna’s growth.

Here’s What You Will Bring to the Table:

• At least 20 years of relevant experience working with engineering project delivery, construction capital projects or 15+ years with master's degree in engineering, preferably in a pharmaceutical/FDA-regulated work environment.

• A professional and advanced degree in Engineering. Chemical Engineering background is preferred.

• 10 or more years’ experience leading others on project teams, interfacing and influencing at executive levels.

• Substantial operational engineering experience

• Broad knowledge of engineering aspects associated with pharmaceutical drug substance and drug product manufacturing

• Knowledge of Quality Assurance (QA) and Environmental, Health & Safety (EHS) standards

• Experience working to regulatory standards: FDA (Food and Drug Administration), Good Engineering Practice (GEP), Good Manufacturing Procedures (GMP) and Good Documentation Procedures (GDP)

• Experienced working on all aspects of capital projects, including budgeting, design, construction, validation, start-up, and ongoing operations will be a plus.

• Relevant experience in Central Utilities including, but not limited to: WFI (Water for Injection), and Purified Water, Compressed Air, N2, Chilled Water, Steam, Heating Hot Water, Electricity and Sewage

• Excellent negotiation, organizational, interpersonal, and problem-solving skills  

• Working Knowledge of Large and Small Molecule manufacturing including fermentation and chemical synthesis. Single use Systems for Upstream and downstream processing. Fill & Finish experience is a plus.

• Working knowledge if key Drug Substance manufacturing technologies such as Fermentation, Tangential Flow Filtration, Chromatography

• Working knowledge if key Drug Product manufacturing technologies such as Aseptic Filling, Isolator Technology, Automatic Visual Inspection, Label & Packaging and Robotics

• Demonstrates strategic enterprise thinking, finding innovative ways to deliver results, and build trust

• Must possess outstanding communication, analytical, and problem-solving skills, and the ability to work with enterprise-wide information systems

• Ability to interact well with other groups and must be able to take ownership of and follow through on assignments.  Must be able to drive results on multiple complex assignments simultaneously with minimal required direction from his/her supervisor.       

• Ability to represent Moderna’s interests, objectives, and policies in a professional and responsible manner.

• Ability to make effective oral presentations and work as part of a team.

• Ability to represent Moderna’s interests, objectives, and policies in a professional and responsible manner.

Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:

• Highly competitive and inclusive medical, dental and vision coverage options
• Flexible Spending Accounts for medical expenses and dependent care expenses
• Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
• Family care benefits, including subsidized back-up care options and on-demand tutoring
• Free premium access to fitness, nutrition, and mindfulness classes 
• Exclusive preferred pricing on Peloton fitness equipment
• Adoption and family-planning benefits
• Dedicated care coordination support for our LGBTQ+ community
• Generous paid time off, including:
  •    Vacation, sick time and holidays
  •    Volunteer time to participate within your community
  •    Discretionary year-end shutdown
  •    Paid sabbatical after 5 years; every 3 years thereafter
• Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
• 401k match and Financial Planning tools
• Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
• Complimentary concierge service including home services research, travel booking, and entertainment requests
• Free parking or subsidized commuter passes
• Location-specific perks and extras!

About Moderna

Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. 

By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.

We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.

If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.

Moderna is a smoke-free, alcohol-free and drug-free work environment.

Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!

Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.

Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We’re focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.

Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Talent Acquisition Partner or contact the Accommodations team at leavesandaccommodations@modernatx.com.  (EEO/AAP Employer) 

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The Role:

The Associate Director of Clinical trial Transparency & disclosure is an incredible opportunity to work under the direct mentorship of our Director or Senior Director of CTTD. The chosen candidate will not just be a part of Moderna’s CTTD team but will lead the charge in delivering high-quality clinical and regulatory disclosure deliverables From masterminding the planning and coordination to spearheading the delivery of final submissions, your role of Associate Director of CTTD will be pivotal. They will be the linchpin connecting the clinical development team, understanding and translating how their work shapes the broader objectives of Moderna’s clinical development program. This is not just a job, it's an opportunity to drive change and make a difference in the world of biotechnology.

Here’s What You’ll Do:

• Functional Knowledge: Possess specialized depth and breadth of knowledge for managing clinical trial transparency and regulatory writing within a clinical development program.

• Document Planning and Project Management: Coordinate and oversee the planning, writing, editing, and review of clinical and regulatory submission documents.

• Cross-functional Collaboration: Work closely with the clinical development team and other departments to ensure alignment and coherence of submission documents.

• Regulatory Compliance: Ensure that all documents comply with regulatory guidelines and standards.

• Data Interpretation: Understand and interpret complex clinical data and other scientific information.

• Disclosure Updates: Regularly update and maintain all global disclosure submissions as needed.

• Problem Solving: Lead others to solve complex problems using multiple sources of information; use sophisticated analytical thought to exercise judgment and identify solutions.

• Impact on the Team: Guided by functional plans, achieve end results and contribute to policy development and planning.

• Develop and Implement Departmental Strategies: Set goals and objectives for the transparency & disclosure team that align with the company's overall strategy.

• Line Management: Manage performance, develop talent, and allocate resources to ensure the successful execution of the department’s Transparency strategy.

Here’s What You’ll Bring to the Table:

• Education: Advanced degree in Life Sciences, Pharmacy, or Medicine.

• Years of Experience: Minimum of 7 years of experience in transparency & disclosure in the pharmaceutical or biotech industry.

• Industry Experience: Proven experience in clinical development, regulatory affairs, and medical affairs.

• Interpersonal Skills: Excellent interpersonal skills to effectively communicate and collaborate with all levels of the organization.

• Leadership Skills: Ability to lead cross-functional projects or programs; manage external vendors.

• Business Expertise: Understanding of the business aspects of biotechnology and the ability to contribute to strategic planning. Knowledge of external market and regulatory factors that may impact CTTD; ability to apply best practices to improve processes and services.

• Communication Skills: Excellent written and verbal communication skills, with the ability to communicate difficult concepts and persuades others to adopt a different point of view.

• Quality: Commitment to quality, ensuring that all work produced meets the highest standards of accuracy and comprehensiveness. High attention to detail, organizational skills, and the ability to manage multiple tasks simultaneously.

• Technical Skills: Proficiency in standard industry software and database systems.

Moderna is pleased to provide you and your family with a comprehensive and innovative suite of benefits, including:

• Highly competitive and inclusive medical, dental and vision coverage options
• Flexible Spending Accounts for medical expenses and dependent care expenses
• Lifestyle Spending Account funds to help you engage in personal enrichment and self-care activities
• Family care benefits, including subsidized back-up care options and on-demand tutoring
• Free premium access to fitness, nutrition, and mindfulness classes 
• Exclusive preferred pricing on Peloton fitness equipment
• Adoption and family-planning benefits
• Dedicated care coordination support for our LGBTQ+ community
• Generous paid time off, including:
  •    Vacation, sick time and holidays
  •    Volunteer time to participate within your community
  •    Discretionary year-end shutdown
  •    Paid sabbatical after 5 years; every 3 years thereafter
• Generous Paid Leave offerings, including 18 weeks of 100% paid parental leave for all new parents
• 401k match and Financial Planning tools
• Moderna-paid Life, LTD and STD insurance coverages, as well as voluntary benefit options
• Complimentary concierge service including home services research, travel booking, and entertainment requests
• Free parking or subsidized commuter passes
• Location-specific perks and extras!

About Moderna

Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world. 

By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.

We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.

If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.

Moderna is a smoke-free, alcohol-free and drug-free work environment.

Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!

Moderna is proud to be an equal opportunity workplace and is an affirmative action employer.

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is an E-Verify Employer in the United States. We also consider qualified applicants regardless of criminal histories, consistent with legal requirements.

Belonging, Inclusion, and Diversity are critical to the success of our company and our impact on society. We’re focused on attracting, retaining, developing, and advancing our employees and believe that by cultivating diverse experiences, backgrounds, and ideas, we can provide an environment where every employee is able to contribute their best.

Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Talent Acquisition Partner or contact the Accommodations team at leavesandaccommodations@modernatx.com.  (EEO/AAP Employer) 

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