Job Summary:

The Program Management Director will support a large USAID global health security (GHS) project, managing cross-functional teams from award through close-out. Provides overall strategic direction for project management support including plans to determine technical implementation, activity scheduling, budget, procedures, staffing, and allotment of resources needed for projects. Identifies specialized partnership needs, engages qualified partners to ensure technical performance. Contributes project experience and learning to global thought leadership initiatives in specific area of technical specialization. Plans and directs schedules and monitors budget/spending. Organizes interdepartmental activities ensuring completion of the project on schedule and within budget constraints. Selects, develops, and evaluates personnel to ensure efficient project implementation. This position will report to the Project Director and act as their backup.This position is contingent upon successful award.

Accountabilities:

• Provide support to the Project Director to ensure the project is implemented in an efficient, compliant, timely and results-oriented manner.
• Serves as the program and country management technical lead and key point of contact for the prime implementing organization on a large project.
• Oversees country programs, working closely with Country Directors, Technical Director, and technical leads to ensure smooth project implementation, tracks performance against project timelines, budget, objectives, and deliverables.
• Establishes work plans, project teams, and SOPs to meet project goals and ensure compliance with organizational and donor policies.
• Plans, directs, and coordinates activities, in coordination with the Technical and Strategic Information Director, to ensure that goals and objectives are accomplished within prescribed time frame and funding parameters.
• Coordinate the provision of technical and management support to established country programs to ensure timely achievement of project objectives and deliverables, e.g. managing employee and consultant hiring process including recruitment, interviewing, and development of solicitations and scopes of work.
• Manage, implement, and monitor systems, services, staff, and budgets to achieve financial, administrative and project goals.
• Provide timely and accurate project reports to FHI 360 and donors, as required.
• Works closely with the Finance Director to develop, review, and monitor approved budgets.
• Identify, escalate and mitigate programmatic and financial risk across the award, including through all subagreements/contracts.
• Oversees execution and management of subs throughout the life of project.
• Ensure compliance with FHI 360 procurement and financial reporting procedures by field-based programs and serving as a resource to field finance and administrative staff on procurement and payment procedures.
• Ensures high quality technical deliverables—including workplans and annual reports—are developed, submitted and approved on schedule and within budget parameters.
• Develops and implements processes and procedures to achieve strategic goals of the project.
• Provides direction to ensure technical activities are compliant with client agreements, government regulations and the organization’s policies and procedures.
• Responds to client requests and questions on project matters and ensures timely drafts and submissions of consents, approvals and/or waivers.
• Recruits, orients, and supervises project staff to support project and ensure the completion of programmatic and workforce planning needs are met and achieved.
• Provide leadership to staff to ensure the development of timely, high quality and regulation compliant reporting per FHI 360 and donor guidelines.
• Provide supportive guidance and supervision to staff, and managers who are charged to implement projects within the assigned area of expertise.
• Collaborate with cross functional groups on matters concerning staff development that leverages international staff to mentor local staff, so as to maintain project accountability and scale in the short term and fast track capacity building for the long term.
• Support performance management and professional development of direct reports, including ongoing feedback, coaching, and career support.
• Performs other duties as assigned.

Applied Knowledge & Skills:

• Effective strategic planning, project evaluation and project management skills.
• Strong business acumen, staff development, management, and reporting experience.
• Strong consultative and negotiation skills.
• Operations management, corporate policies, compliance, and procedures oversight experience.
• Demonstrated public relations and diplomacy skills required.
• Excellent oral and written communication skills.
• Ability to speak the country’s language.
• Ability to build positive local working relationships with local communities, district government officials, UN and where appropriate, donor representatives.
• Ability to analyze and establish effective and supportive cross- project coordination, organizational procedures, and management systems.

Problem Solving & Impact:

• Decisions and actions have a significant impact on management and operations.
• Problems encountered are moderate to complex and highly varied.
• Demonstrates strong critical thinking and problem-solving skills to plan, organize, and manage resources for successful completion of projects.
• Exercises judgment to meet business strategies and develops objectives that align with organizational goals.

Supervision Given/Received:

• Assists in setting goals and budgets for projects and leads the country in achieving strategic goals.
• Leads coordination for fundraising planning and implementing strategies to increase private donor giving.
• Leads coordination of resources for ongoing projects across functional areas and addresses/ resolves issues.
• Typically reports to a Project Director.

Education:

• Bachelor's Degree or its International Equivalent in Business Administration, Public Health, Social Sciences or Related Field.
• Project Management (PM) Certification preferred.

Experience:

• Typically requires a minimum of 12+ years of relevant experience in managing USG projects, specifically USAID, management of GHS projects, and donor, sub-, and partner management.
• Articulate, professional and able to communicate in a clear, positive manner with clients and staff.
• Proficient with applicable rules, regulations, and policies associated with international development and non-governmental organizations (NGOs).

Typical Physical Demands:

• Typical office environment.
• Ability to spend long hours looking at computer screen and doing repetitive work on a keyboard.
• Ability to sit and stand for extended periods of time.
• Ability to lift/move up to 5 lbs.

Technology to be Used:

• Personal Computer/Laptop, Microsoft applications (i.e., Office 365, SharePoint, Skype/Zoom/Teams), cell phone/mobile technology, and standard office equipment.

Travel Requirements:

• 10% - 25%

The expected hiring salary range for this role is listed below. FHI 360 pay ranges represent national averages that vary by geographic location. When determining an offer amount, FHI 360 factors in multiple considerations, including but not limited to: relevant years of experience and education possessed by the applicant, internal equity, business sector, and budget. 

Base salary is only one component of our offer. FHI 360 contributes 12% of monthly base pay to a money purchase pension plan account. Additionally, all US based staff working full-time, which is calculated at 40 hours/week, receive 18 days of paid vacation per year, 12 sick days per year, and 11 holidays per year. Paid time off is reduced pro rata for employees working less than a full-time schedule.

Hiring Salary Range: $128,000 - $183,000

This job posting summarizes the main duties of the job. It neither prescribes nor restricts the exact tasks that may be assigned to carry out these duties. This document should not be construed in any way to represent a contract of employment. Management reserves the right to review and revise this document at any time.

FHI 360 is an equal opportunity and affirmative action employer whereby we do not engage in practices that discriminate against any person employed or seeking employment based on race, color, religion, sex, sexual orientation, gender identity, national or ethnic origin, age, marital status, physical or mental disability, protected Veteran status, or any other characteristic protected under applicable law.

Our values and commitments to safeguarding: FHI 360 is committed to preventing any type of abuse, exploitation and harassment in our work environments and programs, including sexual abuse, exploitation and harassment. FHI 360 takes steps to safeguard the welfare of everyone who engages with our organization and programs and requires that all personnel, including staff members and volunteers, share this commitment and sign our code of conduct. All offers of employment will be subject to appropriate screening checks, including reference, criminal record and terrorism finance checks. FHI 360 also participates in the Inter-Agency Misconduct Disclosure Scheme (MDS), facilitated by the Steering Committee for Humanitarian Response. In line with the MDS, we will request information from job applicants’ previous employers about any substantiated findings of sexual abuse, exploitation and/or harassment during the applicant’s tenure with previous employers. By applying, job applicants confirm their understanding of these recruitment procedures and consent to these screening checks.

FHI 360 will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws.

FHI 360 will never ask you for your career site username or password, and we will never request money, goods or services during the application, recruitment or employment  process. If you have questions or concerns about correspondence from us, please email CareerCenterSupport@fhi360.org.

FHI 360 fosters the strength and health of its workforce through a competitive benefits package, professional development and policies and programs that support a healthy work/life balance. Join our global workforce to make a positive difference for others — and yourself.

Please click here to continue searching FHI 360's Career Portal.

Flowserve is a world-leading manufacturer and aftermarket service provider of comprehensive flow control systems. Driven by our Purpose, we are committed to building a more sustainable future to make the world better for everyone. With more than 16,000 employees in more than 50 countries, we combine our global reach with local presence. We support more than 10,000 customers worldwide, creating products to meet the needs of our customers who are supplying energy, fresh water, pharmaceuticals and other essentials to consumers, businesses and governments globally.

Join a company where the people challenge themselves to approach each situation with ingenuity and creativity to help provide our customers with the most innovative flow control products and services. You will be part of a team known for its industry-leading talent, unparalleled portfolio, and unmatched commitment to customer success. Flowserve’s culture promotes recognition and rewards creativity, hard work, and commitment. We invite you to put your talents and career in motion at Flowserve.

Position Description:

The Director, Health, Safety, and Environment (HSE) Operations role provides expert leadership and guidance to those that manage and/or lead in operations and facilities (cross platform and function). The purpose of this position is to ensure alignment and direction for the Regional HSE Managers to the Divisions and to monitor systems implementation consistency from a high level. This role is also responsible for the development of the HSE Regional Managers to ensure they are able to serve the business.

This position is located in the United States and reports directly to Director, HSE.

Key Responsibilities

• Champion culture change – lead with purpose, core values, and behaviors to promote and fully embed an Enterprise Safety Mindset within all employees across Flowserve

• Support consistent execution of the HSE strategy including programs, plans, policies, and procedures to go beyond governmental compliance requirements to adopt best practices that protect our employees, customers, communities, and physical assets

• Support the continuous improvement of methodology for monitoring, measuring, and achieving HSE objectives to prevent accidents, injuries, and pollution through ongoing improvement programs to operationalize best in class HSE principles

• Promote and implement consistent Safety Accountability actions and mindset across the business

• Lead standardization efforts to ensure all facilities within the enterprise operate under the same policies and procedures and are measured by the same performance metrics

• Provide guidance, coaching, mentoring, development, and leadership for direct and matrix HSE team globally

• Together with the HSE team, build relationships and lead with expert consultation, collaboration, and guidance on safety, health, industrial hygiene, environmental, and fire prevention

• Manage and support the development and consistent implementation of HSE training in our global facilities

Position Requirements:

• 5+ years of experience leading a team

• Bachelor’s degree in Engineering, HSE, Business, or a related field

• Manufacturing, Engineering, Consumer Products or related business experience

Preferences:

• Geographically mobile for development opportunities

• Prior HSE experience in both field locations and corporate environments

• Ability to influence, communicate, and collaborate at all organizational levels

• Expertise with MS Outlook, Word, Excel, and PowerPoint

Flowserve offers competitive pay, annual bonuses, medical benefits on day 1, generous paid vacation time, paid holidays, 401(k) and many other excellent benefits!

Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.

Early Development Associate Medical Director, Inflammation Therapeutic Area

Live

What you will do

Let’s do this. Let’s change the world. In this vital role you will be responsible for designing and executing early development clinical trials and leading the evidence generation teams. You will report into the Executive Director, Head of Early Development Inflammation and Rare Disease.

• Effectively network with internal and external opinion leaders

• Design and implement an early clinical development strategy for Inflammation indications (e.g., rheumatologic, respiratory, dermatologic, inflammatory bowel disease, other)

• Opportunity to explore additional therapeutic areas, e.g., rare diseases,

• Lead the preparation of clinical development plans and clinical study protocols, and contribute to informed consents, Investigator Brochures, and Ethics Committee and regulatory agency submissions

• Lead the Evidence Generation Team

• Review and evaluate clinical study safety, efficacy, pharmacodynamic and pharmacokinetic data

• Contribute to the strategy and use of clinical biomarkers to facilitate drug development

• Actively collaborate with Amgen Late Development, Discovery Research, Regulatory, and Commercial colleagues

• Collaborate with external experts to provide biomedical expertise and strategic guidance to inflammation early development teams

• Contribute to in-licensing evaluations and due-diligence activities

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications.

Basic Qualifications:

Doctorate degree and 3 years of academic/basic sciences/clinical research experience

OR

Master’s degree and 5 years of academic/basic sciences/clinical research experience

OR

Bachelor’s degree and 7 years of academic/basic sciences/clinical research experience

OR

Associate’s degree and 12 years of academic/basic sciences/clinical research experience

OR

High school diploma / GED and 14 years of academic/basic sciences/clinical research experience

Preferred Qualifications:

• Board certification or eligible

• Residency training in Internal Medicine and relevant subspecialty

• 3+ years of Inflammation drug development experience in the pharmaceutical industry and/or substantial clinical trial

• Experience collaborating with pharmaceutical sponsors

• Experience in designing, monitoring and implementing clinical trials and interpreting trial results

• Demonstrated leadership qualities, capable of conducting studies as part of a team

• Experience within a matrix environment, contributes to decision-making and reaching alignment in order to meet timelines

• Experience in early clinical trials

• Experience in basic research and clinical trial methodology

• Publication track record

• Excellent interpersonal and presentation skills

• Communicate effectively with internal stakeholders, as well as external partners and collaborators

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.

• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan

• Stock-based long-term incentives

• Award-winning time-off plans and bi-annual company-wide shutdowns

• Flexible work models, including remote work arrangements, where possible

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Salary Range

Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.

Director, Oncology Research

Live

What you will do

Let’s do this. Let’s change the world. Amgen Oncology is advancing an innovative, multi-modality pipeline that aims to transform the cancer treatment landscape. We are seeking a creative, collaborative Director of Research who is driven to deliver next-generation BiTE® (bispecific T-cell engager) therapies.

In this vital role, you will be responsible to develop our strategy for new target discovery and validation, and to build a portfolio of preclinical T-cell engager assets focused on solid tumors. The Director will be closely involved in the identification and assessment of internal and external opportunities for technology and platform development to support this strategy. A deep understanding of cancer cell biology and human genetics, broad knowledge of the oncology competitive landscape, and experience with drug discovery and development across therapeutic modalities is required. This is a high visibility role.

Responsibilities:

• Work as part of a cross-functional team to identify strategic opportunities to build the portfolio;
• Identify, evaluate, and implement cutting-edge approaches for target identification and validation;
• Lead the advancement of high quality targets and assets in the early Oncology portfolio
• Develop a research team that includes laboratory-based staff, managers, and project team leaders;
• Establish and maintain external partnerships (academic and/or industry) and presence
• Present strategy, opportunities, and project updates to senior leadership
• Demonstrate critical thinking and efficient decision-making

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications.

Basic Qualifications:

Doctorate degree PhD OR PharmD OR MD [and relevant post-doc where applicable] and 5 years of related experience

Or

Master’s degree and 8 years of related experience

Or

Bachelor’s degree and 10 years of related experience

Preferred Qualifications:

• PhD in cancer biology, human genetics, biochemistry, or immunology with at least 10 years post-graduate experience
• Leadership style that is highly collaborative, inspires and develops talent at all levels, and puts patients and science first
• Deep understanding of cancer cell biology and therapeutic development
• Proven scientific accomplishment and innovation in oncology research as evidenced by high-impact publications, congress presentations and patents
• Experience leading academic or industry research collaborations
• Outstanding interpersonal and communication skills

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans and bi-annual company-wide shutdowns
• Flexible work models, including remote work arrangements, where possible

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Salary Range

What Global Trade contributes to Cardinal Health
Global Trade is responsible for the design, implementation and execution of policies, programs, and platforms to enable compliant and efficient international movement of products and technologies.
 

Global Trade Sourcing is responsible for defining the domestic and/or international logistics strategy by establishing strategic relations with service providers. This job family owns US and global logistics T&C’s, contracts, negotiations, supplier performance metrics and supplier vetting and evaluation. 

Job Summary

The Director of Global Trade Transformation requires the background, experience, and leadership skills necessary to provide effective global trade, transportation, and project management. The position is responsible for managing timelines and execution of processes for center led initiatives, managed services, process improvements and change management. The position reports to the Sr. Vice President of Global Logistics. Responsibilities include investigating, analyzing, evaluating, and implementing long term strategic planning, coordinating timelines, communication, and transition activities. Additional responsibilities include process rationalization and optimizing costs.

Accountabilities

• Serve as Cardinal Health’s Licensed Customs Broker.

• Drive trade compliance excellence across Cardinal Health.

• Assist in the development, maintenance, and implementation of trade compliance policies and procedures across the corporation.

• Provide proactive global trade risk assessment/updates to ensure corporate alignment with the ever-changing global trade landscape; provide recommendations and lead the implementation of new policies and measurable process improvements.

• Support Global Brokerage Rationalization, Strategy and RFQ.

• Review and monitor documentation of import/export management processes and control systems in accordance with Global Import and Export regulations, corporate policy, and industry best practices.

• Support supply chain optimization initiatives to minimize costs and risk.

• Develop formal customs and trade compliance educational and/or training programs or e-Learnings.

• Develop a Global Trade network across multiple business units at Cardinal Health.

• Experience and knowledge of import/export methods and procedures and global operations, understanding of current events and changing landscapes and the trade compliance impacts to the supply chain.

• Support continuous improvement initiatives to enhance the quality of workflows, templates, and processes; maintain project timelines.

• Manage, maintain, and update project related procedures, standard work, and templates.

• Manage and maintain recordkeeping practices in accordance with Global Government regulations and company policies.

• Assist in other risk management projects as assigned.

• Support, maintain and develop duty impact analysis opportunities (Drawback, FTZ/MPF, Recon, FTA and Automation).

• Develop requirements to manage a Cardinal Health Global Trade Management System.

Qualifications

• Bachelor’s or advanced degree in International trade preferred

• Licensed US Customs Broker

• 10-15+ years’ work experience in Trade Compliance, with proficient knowledge of US customs and trade sanctions regulations and standards highly preferred

• International Business experience working for large multinational companies highly preferred

• Proven success collaborating with cross-functional stakeholders to drive continuous improvement initiatives that increase compliance with global trade regulations

• Highly experienced working with global teams and government agencies

• Experience developing and overseeing the development of training on trade compliance topics

• Experience managing multiple priorities and escalations with tight timelines in a fast-paced, changing environment

• Ability and willingness to travel up to 40% (regular travel to corporate headquarters in Dublin/Columbus, OH)

Anticipated pay range: $146,900-$226,000

Bonus eligible: Yes

Benefits: Cardinal Health offers a wide variety of benefits and programs to support health and well-being.

• Medical, dental and vision coverage
• Paid time off plan
• Health savings account (HSA)
• 401k savings plan
• Access to wages before pay day with myFlexPay
• Flexible spending accounts (FSAs)
• Short- and long-term disability coverage
• Work-Life resources
• Paid parental leave
• Healthy lifestyle programs

Application window anticipated to close: 05/16/2024. If interested in opportunity, please submit application as soon as possible.

Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply.

Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.

To read and review this privacy notice click here

Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.

Medical Sciences Director - Early Development - Hematology/Oncology, US - Remote

Live

What you will do

Let’s do this. Let’s change the world. Amgen is advancing the largest early Oncology pipeline in our history spanning several innovative technology platforms – Bispecific T Cell Engagers (BiTE®s), Bispecific Antibodies, Small Molecules – across many targets and more than a dozen tumor types. We need collaborative and innovative world-class talent to ensure these molecules become medicines and reach their full potential while helping patients.

To support that effort, the Oncology Early Development Group is looking for a Medical Sciences Director.

In this vital role, the Medical Sciences Director will contribute to early phase clinical development of oncology compounds from first-in-human studies through proof of concept. They will collaborate on teams to define, design, and deliver early phase clinical and translational projects as the initial strategy for drug development. Through their role, the Medical Sciences Director provides subject matter expertise in data review and analysis.

Responsibilities:

• Assist with set up and execution of early phase clinical trials with a focus on data quality
• Responsible for providing input into & implementation of data management plan, CRF design, and data review oversight
• Accountable for review, analysis, and presentation of clinical trial data for internal decision making, external interactions, and regulatory submission
• Assists Early Development Lead in medical monitoring and management of oncology phase 1 collaborators, consultants, and/or Clinical Research Organizations in completion of key projects
• Anticipate and actively manage problems across a broad spectrum of cross-functional teams
• Work cross functionally within teams to ensure clinical strategy is translated into the development of the study concept document, study protocol and related documents

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The medical professional we seek is a leader with these qualifications.

Basic Qualifications:

Doctorate degree and 4 years of medical science experience
OR
Master’s degree and 7  years of  medical science experience 
OR
Bachelor’s degree and 9 years of medical science experience
 

Preferred Qualifications:

• 5 years of pharmaceutical clinical drug development experience
• Strong preference for individuals with proven track record of oncology clinical trial process improvement
• Industry or academic experience in early-phase oncology drug development
• Strong communication & presentation skills to clearly communicate scientific concepts /data to leadership committees both internally or externally (both written and oral)
• Experience with designing, monitoring, and implementing oncology clinical trials and interpreting test results in compliance with Good Clinical Practice standards and regulatory requirements
• Understanding of conducting study data readout activities, including data cleaning, data base lock, data extract, producing outputs of data
• Experience drafting high level submission documents for regulatory submissions including authoring clinical regulatory responses for health regulatory interactions
• Serving as a contributing author to scientific publications and data presentations at scientific conferences
• Experience in clinical data analysis such as Spotfire or other data analysis tools
   

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

In addition to the base salary, Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans and bi-annual company-wide shutdowns
• Flexible work models, including remote work arrangements, where possible

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Salary Range

Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.

Global Marketing Director, Oncology

For nearly four decades, Amgen has been at the forefront of providing the oncology and hematology communities with novel therapies that have changed patients’ lives.

We have pioneered first-in-class oncology and hematology medicines including, LUMAKRAS®. BLINCYTO®, Neupogen®, Nplate®, XGEVA®, BLINCYTO® and IMLYGIC®

We are building upon our solid oncology foundation and long-term commitment to patients by developing a whole new class of novel molecules – and we need top talent to ensure these molecules become medicines and realize their potential for helping patients.

Today, Amgen is advancing the largest early Oncology pipeline in our history spanning several innovative technology platforms, across many targets and more than a dozen tumor types.

Many of these innovative modalities/technologies are not only firsts for Amgen, but also for the entire biotechnology field. By joining our team, you will help us seize the opportunities that come with paving new roads – roads that ultimately lead to directly serving oncology patients.

Live

What you will do

Let’s do this. Let’s change the world! In this vital role the Global Marketing Director is a critical role in the organization and has a significant impact in driving strategy and execution on products at all stages of the product lifecycle. For peri-launch products, including tarlatamab, the Global Marketing Director is responsible for maximizing the value of the asset within key indications, providing commercial guidance and vision, developing global launch strategies, anticipating lifecycle management opportunities to enhance the customer experience and competitive position, and optimizing the impact of marketing budgets.

Tarlatamab (AMG 757) is currently being developed for the treatment of both extensive and limited-stage small-cell lung cancer (ES- and LS-SCLC); providing commercial leadership to the development organization, you will be responsible for ensuring that this compound is developed with the future market in mind and in-parallel to late-stage indications.

This role will involve working with leaders across oncology to ensure that the insights and market learnings generated for other thoracic oncology marketed products (LUMAKRAS), other peri-launch assets (e.g., bemarituzumab) are appropriately incorporated into the commercial strategy for tarlatamab. It will also involve working closely with Amgen’s integrated brand team and brand working group selected local countries to integrate local market insights. In addition to the above responsibilities, this role will support broad strategic initiatives pertaining to the portfolio such as tumor-level patient insights, patient centric development, journeys and preferences, lifecycle management planning, and ‘global to local’ readiness plans.

This role will report to the Global Marketing Lead for tarlatamab.

Key responsibilities include:

• Working with the Global Marketing Lead to gather deep insights into the customer, marketplace, competitors, and business drivers and develop a “gold standard” commercial strategy designed to optimize the future value of key indications for tarlatamab (including limited stage and extensive-stage front-line, second-line).

• Key contributor to relevant Insights and Brand teams and global marketing activities for assigned brands. Ensure that all portal decisions are supported by a robust commercial assessment including but not limited to an understanding of portfolio fit and organizational impact.

• Lead key marketing deliverables requiring cross-functional stakeholder alignment and input (e.g., Brand Planning).

• Ensure all marketing deliverables for assigned brands are on time and of expected quality in alignment with Amgen’s processes and requirements. These include contributions to Global Product Strategy, competitive insights, patient-centric deliverables, robust Target Product. Profiles, Forecasts, and strategies to enhance program value including LCM.

• Communicate commercial vision for disease-state for tarlatamab.

• Partner with launch markets for Launch Readiness Exercises (LRR).

• Lead for Commercial advisory boards.

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a collaborative leader with these qualifications.

Basic Qualifications:

Doctorate degree and 4 years of marketing experience

Or

Master’s degree and 7 years of marketing experience

Or

Bachelor’s degree and 9 years of marketing experience

Preferred Qualifications:

• An MBA, coupled with a life sciences educational background.

• 8+ years of experience and a track record of success in a series of commercial roles of increasing scope, scale and complexity, with leading companies in the biopharmaceutical industry.

• A best-in-class marketer with experience developing and implementing innovative global marketing and commercial strategies for pipeline products, successfully launching therapeutic products and repositioning products to maximize commercial value. Prior experience launching multiple products in diverse therapeutic areas. A solid foundation in strategic marketing.

• Strong experience in Oncology therapeutic area, and solid tumor immuno-oncology. Keen understanding of the science, market trends, and future opportunities and hurdles.

• Strong experience in “beyond the molecule” value drivers such as patient services, as well as CDx/IVD space.

• Prior experience in commercial positions with global responsibilities is important. Experience living and working outside the United States is highly desirable. Possesses an understanding of broad, global market dynamics and the cultural awareness and sensitivity to form relationships and work effectively with colleagues around the world.

• Broad therapeutic area expertise. Has worked in diverse commercial roles supporting several different disease states, on products in various stages of the lifecycle, with a diverse set of customers in challenging and competitive markets. Experience supporting partnered assets/programs.

• Prior experience in a tactical, “line” marketing role, implementing marketing strategies in local markets. Solid understanding of global market access, pricing and reimbursement issues.

• Experience leading cross-functional teams in a matrix environment, managing global projects involving multiple functions and shared accountabilities.

• A scientifically curious mind.

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.

• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan

• Stock-based long-term incentives

• Award-winning time-off plans and bi-annual company-wide shutdowns

• Flexible work models, including remote work arrangements, where possible

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Salary Range

Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.

CDnA - Competitive Intelligence Associate Director, Oncology/Gen Med/Inflammation

Live

What you will do

Let’s do this. Let’s change the world. In this vital role you will lead intelligence gathering activities for US and Global marketing teams to support multiple assets across in one of Amgen’s business units covering Oncology/General Medicine (including Obesity)/Inflammation. This critical role will report to the Senior Director of Competitive Intelligence.

Flexible Commuter role to Thousand Oaks, CA office. You will work on-site 2-3 days a week.

• Be a strategic thought partner to key collaborators across disease area, brand, corporate, and other cross-functional teams supporting the corresponding business unit (OBU/GMBU/INBU)
• Synthesize information from multiple sources to develop strategic insights and point of view on key competitive developments, implications to Amgen and actions Amgen must take.
• Work in a highly cross functional manner and manage changing priorities across several key customers.
• Develop productive relationships with Global and Regional teams to define business problems and develop integrated analysis plans based on standard methodologies.
• Apply structured problem solving to collect, analyze and report CI, incorporating primary and secondary data sources to generate meaningful insights.
• Articulate and educate customers on the relevant impact of changing market dynamics to their business from a CI perspective.
• Organize and facilitate strategic exercises & competitive simulations to generate competitive insights and company plans.
• Coordinate and facilitate CI collection efforts at major medical conferences/congresses.
• Manage a network of primary data sources, including vendors and Amgen employees, to enable effective project delivery.
• Assess the reliability of CI research findings, maintaining high standards for accuracy, relevance, and quality in deliverables at all times and communicate level of evidence to key partners.
• Present on a regular basis in-depth analyses and summaries of results, interpreting and communicating results with recommendations to key stakeholders.
• Work to grow competitive intelligence/strategy to support other functions in the organization.
• Abide by and strictly enforce Amgen’s CI Legal and Ethical Guidelines with internal colleagues and agencies.
• Some travel (15-20%) required.

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a collaborator with these qualifications.

Basic Qualifications:

Doctorate degree and 3 years of competitive intelligence/consulting/equity research/industry experience

OR

Master’s degree and 5 years of competitive intelligence/consulting/equity research/industry experience

OR

Bachelor’s degree and 7 years of competitive intelligence/consulting/equity research/industry experience

OR

Associate’s degree and 12 years of competitive intelligence/consulting/equity research/industry experience

OR

High school diploma / GED and 14 years of competitive intelligence/consulting/equity research/industry experience

Preferred Qualifications:

• Doctorate degree and 4 years , Master's and 5 years, Bachelor's and 8 years
• Advanced degree (PhD/PharmD,MBA)with a focus on life sciences and business
• Experience with previous CI/consulting/equity research/biopharma experience is highly desired
• Relevant experience in Oncology/Obesity/Inflammation via prior project work, disease area knowledge, marketing/sales experience, etc.
• Prior experience in strategy/management consulting in the biopharma industry preferably through a lead role
• Consistent track record of influencing key business decisions through thoughtful insights and recommendations
• Demonstrated ability to think strategically and analyze data to support critical business decisions
• Excellent oral, written, and presentation skills—able to explain complex concepts clearly to a variety of audiences
• Evident project management skills—able to manage multiple, simultaneous projects and data sources
• Demonstrated analytical skills—understands the advantages and limits of different analytical approaches and studies
• Ability to work collaboratively in team-based environment
• Strong understanding of the latest developments and trends in the space, key competitive dynamics and unmet medical needs
• Understanding of at least one other functional area in CD&A (forecasting, market research, and secondary analytics)
• Experience in insights generation for the biopharmaceutical (or other healthcare) industries

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans and bi-annual company-wide shutdowns
• Flexible work models, including remote work arrangements, where possible

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Salary Range

Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.

Clinical Research Medical Director

Live

What you will do

Let’s do this. Let’s change the world. In this vital role you will serve as clinical expert to provide clinical/scientific knowledge into the development, delivery and communication of the global scientific/medical evidence plan for the assigned indication(s).

• Serve as clinical expert to provide clinical/scientific knowledge into the development, delivery and communication of the global scientific/medical evidence plan for the indication(s).

• Provide oversight of LCM clinical development with input on global strategy

• Support cross-functional and global collaborations to integrate broad medical, regulatory, safety, scientific, and commercial access, and value input into the development program(s)

• Participate and provide clinical input into safety and regulatory interactions.

• Interpret and communicate clinical trial data.

• Author/review protocols, CSRs, publications, and regulatory submissions

• Develop key opinion leaders and make scientific presentation at advisory boards, key scientific meetings and external committee meetings as delegated by GDL.

• Identify new clinical research opportunities.

• Support in-licensing and out-licensing activities and partner relationships Support product lifecycle management for new indications as directed by Global Development Lead

• Provide clinical content input to materials to be used in Scientific Affairs as well as the Commercial Organization

• Approximate 10% travel may be required.

• This is a potential managerial role, successful prior experience seeking and developing talent is a plus.

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The medical professional we seek is a leader with these qualifications.

Basic Qualifications:

MD or DO degree from an accredited medical school

AND

2 years of clinical research experience and/or basic science research

Preferred Qualifications:

• MD plus accredited residency in relevant sub-specialty, board certified or equivalent.

• Three (3) or more years of clinical development experience and/or basic science research combined with clinical teaching and patient care activities.

• Clinical development experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO company)

• Experience in development lifecycle management to include development strategy creation for large programs from early development, through late development and commercialization.

• Involved in filing activities as part of the moving the program through the development lifecycle.

• Key relationship development and collaboration with the expansive commercial and medical teams internal and external partners and key opinion leaders.

• Previous management experience of clinical development professionals

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.

• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan

• Stock-based long-term incentives

• Award-winning time-off plans and bi-annual company-wide shutdowns

• Flexible work models, including remote work arrangements, where possible

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Salary Range

Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.

Clinical Research Medical Director, Inflammation

Live

What you will do

Let’s do this. Let’s change the world. The Inflammation Therapeutic Area within Global Development is rapidly growing and in this vital role you will have an opportunity to shape this Therapeutic Area. This role will report directly to the Global Development Lead for a program. The position is US - Remote.

Responsibilities:

• Serve as clinical expert to provide clinical/scientific knowledge into the development, execution and communication of the global scientific/medical evidence plan for the indication(s).

• Provide oversight of LCM clinical development with input on global strategy
• Support cross-functional and global collaborations to integrate broad medical, regulatory, safety, scientific, and commercial access and value input into the development program(s)

• Participate and provide clinical input into safety and regulatory interactions

• Interpret and communicate clinical trial data

• Author/review CSRs, publications and regulatory submissions

  Develop key opinion leaders and make scientific presentation at advisory boards, key scientific meetings and external committee meetings as delegated by GDL

• Identify new clinical research opportunities

• Support in-licensing and out-licensing activities and partner relationships Support product lifecycle management for new indications as directed by Global Development Lead

• Provide clinical content input to materials to be used in Scientific Affairs as well as the Commercial Organization

• Approximate 10% travel may be require

• Potential managerial role, seeking and developing talent in past will be a plus

Knowledge:

• In-depth understanding of the scientific method and clinical applications based on medical, scientific and practical rationale

• In-depth understanding of and proven success in how to conceptualize, design, and conduct complex, global clinical trials in all phases of development esp Ph2/3 registrational trials

• Medical knowledge in the relevant therapeutic area

• Sound scientific and clinical judgment

• Understanding of regulatory agency organization, guidelines, and practices and ability to negotiate with these groups

• Knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, and applicable international regulatory requirements

• Prior experience of regulatory interactions, authoring filing IND or BLA experience

• Understanding of new drug commercialization and business practices

• Understanding of resourcing and budgeting

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Medical professional we seek is a leader with these qualifications.

Basic Qualifications:

MD or DO degree from an accredited medical school

AND

2 years of clinical research experience and/or basic science research

Preferred Qualifications:

• MD plus accredited residency in relevant sub-specialty, board certified or equivalent.
• Three (3) or more years of clinical development experience and/or basic science research combined with clinical teaching and patient care activities.
• Clinical development experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO company)
• Experience in development lifecycle management to include development strategy creation for large programs from early development, through late development and commercialization.
• Involved in filing activities as part of the moving the program through the development lifecycle.
• Key relationship development and collaboration with the expansive commercial and medical teams internal and external partners and key opinion leaders.
• Previous management experience of clinical development professionals

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

The annual base salary range for this opportunity in the U.S. is $256,334. - $318,868.

In addition to the base salary, Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans and bi-annual company-wide shutdowns
• Flexible work models, including remote work arrangements, where possible

Apply now

for a career that defies imagination

In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.

careers.amgen.com

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Salary Range

Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.

Global Asset Lead Medical Director, Oncology Solid Tumor Pipeline, US-Remote

Live

What you will do

Let’s do this. Let’s change the world. In this vital role the Global Asset Lead Medical Director, Oncology Solid Tumor Pipeline will be accountable for development and execution of the global medical affairs strategy for one of Amgen's promising solid tumor pipeline assets. The Asset Lead Medical Director will also be accountable for Global Medical Affairs Team (GMAT) with the objective of maximizing Amgen’s value proposition.

Responsibilities:

• Lead the cross-functional and cross-regional development of the global medical affairs strategies for one of Amgen's pipeline asset through the GMAT
• Provide support for the development and execution of the clinical development plan
• Actively provide insights and support the development of the early Target Product Profile
• Coordinate with the regions to develop and lead the external stakeholder management plan, communication strategy, scientific platform, publication plan and evidence generation plans
• Develop robust external stakeholder engagement and insight gathering to strengthen understanding of the unmet need and maximize medical value of the asset
• Enhance Amgen’s reputation as a science-based and patient focused reliable partner
• Partner on evidence generation and ensure key regional/local needs are addressed

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The medical professional we seek is a leader with these qualifications.

Basic Qualifications:

MD/DO degree from an accredited medical school OR PhD OR PharmD

AND

2 years of Medical Affairs experience in Hematology-Oncology

Preferred Qualifications:

• MD plus accredited fellowship in Oncology, board certified or board eligible
• Clinical and disease knowledge base in solid tumor (specifically thoracic or I-O)
• 4+ years Hematology or Oncology Medical Affairs experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO) that includes collaborations with integrated delivery networks, accountable care organizations, and/or payers
• 2+ years of clinical research experience and/or basic science combined with clinical teaching and patient care activities
• Familiarity with global regulatory organizations, guidelines, and practices
• Knowledge of Good Clinical Practices (GCP) and global regulations and guidelines
• History of solving problems while exhibiting superior judgment and a balanced, realistic understanding of issues
• Knowledge of pharmaceutical product development, product lifecycle, and commercialization processes, including but not limited to, clinical operations, commercial, regulatory, and medical affairs

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

The annual base salary range for this opportunity in the U.S. is $232,290. to $284,490.

In addition to the base salary, Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans and bi-annual company-wide shutdowns
• Flexible work models, including remote work arrangements, where possible

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Salary Range

Job Description

Vertex Pharmaceuticals is seeking a Health Economics & Outcomes Research (HEOR) Associate Director - pain to join the North America HEOR team.  This role will support and develop key HEOR tactics to ensure successful commercialization of novel NaV 1.8 inhibitors for acute and chronic pain in the United States (US) and Canada. This person will work in a highly cross-functional matrix team environment to ensure a seamless alignment of HEOR projects within the broader market access, policy, and medical strategy.  This person is expected to exhibit a strong sense of urgency to achieve corporate objectives while maintaining the highest ethical, regulatory and scientific standards.  This position reports to the Director, Pain launch lead, North America HEOR.

Key Responsibilities

• Own development of tactics for innovative HEOR solutions and deliverables that directly support optimal patient access to in the US and Canada throughout the product’s lifecycle  
• Drive the development of external customer-facing value demonstration tools in accordance with regulatory standards, in close collaboration with formal review bodies (e.g., Commercial Review Committee; Medical Review Committee) while supporting appropriate field teams (e.g., field HEOR, payer team)
• Work closely with global HEOR team to provide the US and Canadian perspective to evidence generation activities and to ensure timely and effective translation of HEOR studies for field use
• Directly engage with external customers (e.g., payer accounts) to deliver HEOR presentations when appropriate/requested
• Own execution of local HEOR studies in partnership with customers (e.g., payers, integrated health systems)

Qualifications

• Advanced degree (e.g. PhD, MD, MPH, or PharmD) in a scientific discipline.  
• Typically requires 8+ years of experience, with substantial background in HEOR, or the equivalent combination of education and experience. US launch experience in pain and/or other primary market experience is preferred.
• Robust understanding of the 2018 FDA Payor Guidance to payer communication in the US is strongly preferred.
• Understanding of the HTA process and methodology; hands-on experience with HTA dossier submission and review is preferred.
• A track record of peer-reviewed publications demonstrating experience in COAs, observational research, and/or health economic modeling.
• Strong communication skills, both verbal and written, including the ability to effectively present to both internal and external audiences
• Results oriented and excellent analytic and project management skills. 
• A strong sense of urgency and commitment to patients

This is a hybrid eligible role requiring at least 3 days on-site in Boston office.

#LI-KM3

#LI-Hybrid

Company Information

Job Description

The Senior Medical Director, Patient Safety, Disease Area Safety Head (DASH) will lead all safety and benefit-risk related activities for products within the role's Disease-area and/or Franchise, including pre-franchise products from first in-human clinical trials, into and throughout commercialization. This role will assist Global Patient Safety (GPS) Leadership in ensuring the consistency and compliance in the safety assessment, analysis and reporting for all designated product(s) throughout Vertex’s world markets. Directly and/or via oversight of direct reports, the role will lead pre-marketing risk assessment, planning for First-In-Human (FIH) studies, safety content of key Modules (SCS, CLO, Labelling) in regulatory authority submissions for approval, including planning, content and execution of Risk Management Plans (RMPs) and/or Risk Evaluation and Mitigation Strategies (REMS) for and post-marketing requirements. The role will work closely with the program specific Clinical Teams, Medical Affairs, and Partners (as applicable) to proactively assess and address potential and identified safety issues for each product throughout the product life cycle.

Key Duties and Responsibilities:

• Provides leadership and oversight of Safety Team(s) for products within assigned therapeutic area(s), including pre-FIH activities, benefit-risk assessment, and strategy for DSTs.

• Coordinates and oversees safety signals detection, in accordance with Vertex signal detection practices.

• Collaborates with Clinical Leaders to develop and implement appropriate Risk Management procedures/plans for each product, as needed.

• Collaborates with NDA teams in support of submissions, specifically leading development of any SCS, CLO, Label and Risk Management Plan (RMP) or equivalent documents.

• Collaborates with GPS Epidemiology with regards to development, implementation and reporting of pharmacoepidemiology studies.

• Reviews and/or assists in preparation of Developmental and/or Post-Marketing Periodic Safety Updates (D/PSURs), IND packages, as well as NDA and IND, MAA Annual Safety Reports.

• Provides review and safety-specific input for labeling documents.

• Collaborates with Regulatory Affairs to develop responses to safety related regulatory agency inquiries.

• Provides and oversees medical review of aggregate and individual post-marketing and clinical trial AE reports, in accordance with GPS review practices.

• Conducts medical evaluation of relevant safety information from Toxicology, Non-Clinical studies and Product Quality sources.

• Reviews and provides oversight for medical content for key study-related documents, e.g., Protocols, Analysis Plan, IB, ICF and IDMC Charter.

• Reviews and provides oversight in the analysis of safety data from on-going and completed clinical trials and Study Reports.

• Provides contributory to Partner /Affiliate agreements and interactions, as needed.

• Serves as Subject Matter Expert in departmental activities, SOP development.

• Facilitates the growth and development of staff and direct reports.

Knowledge and Skills:

• Broad and comprehensive knowledge of General Medicine

• Extensive knowledge of GCP, ICH and Global regulations

• Strong leadership skills with the ability to communicate effectively in a matrix environment

• Experience in the critical evaluation and interpretation of data, with ability to synthesize into coherent messaging

• Comprehensive knowledge of Benefit-Risk strategies and decision-making

• Ability to multi-task, adeptly handling multiple demands

Education and Experience:

• Doctorate in Medicine (M.D.) required

• 7+ years of work experience with some experience in Pharmacovigilance and 5 years of supervisory/management experience, or the equivalent combination of education and experience

Company Information

Job Description

The Executive Medical Director, Patient Safety/Head Medical Safety and Risk Management will oversee all safety and benefit-risk related activities of the GPS Physician (Disease-area Safety Heads, DST Chairs) and the Aggregate Report Risk Management (ARRM) Groups within the Vertex Global Patient Safety (GPS) Department. As a member of the GPS Senior Leadership Team, the role will contribute to ensuring consistency and compliance in the safety assessment, analysis and reporting for all designated product(s) throughout Vertex’s world markets. Overseeing the GPS DASH/DST teams across therapeutic areas, the role will ensure consistent conduct and timely execution of Benefit-Risk activities by GPS DASH/DST teams, including pre-marketing risk assessment, planning for First-In-Human (FIH) studies, safety content of key Modules (SCS, CLO, Labelling) in regulatory authority submissions for approval, including planning, content and execution of Risk Management Plans (RMPs) and/or Risk Evaluation and Mitigation Strategies (REMS) for and post-marketing requirements. The role will work closely with leaders from cross-functional teams on the successful achievement of key strategic activities, initiatives and deliverables.

Key Duties and Responsibilities:

• Provides leadership and oversight of DASH/Disease-area Safety Team(s) (DST) conduct, for all products across the Vertex Portfolio, including pre-FIH activities, key benefit-risk assessment, and providing strategy for DSTs to meet goals and objectives.

• Coordinates and oversees the consistent and timely review of safety data for identification of new safety signals, in accordance with Vertex signal detection practices.

• Collaborates with Clinical Leaders to develop and implement appropriate Risk Management procedures/plans for each product, both pre-approval and post-approval, as needed.

• Collaborates with NDA teams assessment, strategy and execution of key Regulatory Authority documents in support of submissions, specifically leading safety content of key Modules (SCS, CLO, Labelling) and development of any Risk Evaluation and Mitigation Strategy (REMS), Risk Management Plan (RMP) or equivalent documents.

• Collaborates with GPS Epidemiology with regards to development, implementation and reporting of pharmacoepidemiology studies, as needed.

• Reviews and/or assists in preparation of Developmental and/or Post-Marketing Periodic Safety Updates (DSURs, PSURs/PBRERs), IND packages, as well as NDA and INDs.

• Provides review and safety-specific input for labeling documents, including IB, CCDS, USPI, SmPC and other local labels, as applicable.

• Collaborates with Regulatory Affairs to develop responses to any safety related regulatory agency inquiries.

• Provides and oversees medical review of aggregate and/or individual post-marketing and clinical trial adverse event reports, in accordance with GPS review practices.

• Oversees medical evaluation of other relevant non-AE/SAE related safety information, such as from Toxicology, Non-Clinical studies and Product Quality sources.

• Reviews and provides oversight for medical content for key study-related documents, e.g., Protocols, Statistical Analysis Plan, IB, ICF and IDMC Charter.

• Reviews and provides oversight in the analysis of safety data from on-going and completed clinical trials and representation in Clinical Study Reports.

• Reviews and provides oversight of safety sections of clinical study reports.

• Provides a contributory role in Partner /Affiliate agreements and interactions, as needed.

• Serves as Subject Matter Expert in departmental development activities including SOP and Work Instructions development.

• Leads Medical staff and liaise with Operations leads regarding optimal practice regarding collection, evaluation and processing of adverse experience reports, from a medical perspective.

• Leads and guides direct reports, regarding the scope of DASH/DST Chair Physician responsibilities, and the provision of sound medical input for all pre-marketing and post-marketing activities.

• Facilitates the growth and development of staff and direct reports.

Knowledge and Skills:

• Extensive knowledge of GCP, ICH and Global regulations.

• In-depth and comprehensive knowledge of General Medicine.

• Strong leadership skills with the ability to communicate effectively in a matrix environment.

• Experience in the critical evaluation and interpretation of data, with ability to synthesize into clear, coherent messaging.

• Extensive knowledge of Benefit-Risk strategies and decision-making.

• Ability to multi-task, adeptly handling multiple demands.

Education and Experience:

• MD, DO or equivalent ex-US medical degree

• 12+ years of work experience with experience in Pharmacovigilance and 7 years of supervisory/management experience, or the equivalent combination of education and experience

Company Information

Career Category

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.

Medical Director, Global Asset Lead, Obesity and Cardio-Metabolism, US- Remote

Live

What you will do

Let’s do this. Let’s change the world. In this vital role the Global Asset Lead Medical Director will be accountable for the development and execution of global medical affairs strategy for Obesity and Cardio-Metabolism.

Responsibilities:

Strategy Development and Implementation:

• Contribute to the development and execution of the global medical affairs strategy for maridebart cafraglutide.
• Serve as the Medical Affairs Representative on various global strategic teams.
• Support the development of the integrated evidence generation plan for obesity and cardio-metabolism.
• Capture clinical/scientific insights across all key markets and translate them into concrete strategies.
• Facilitate scientific engagements across a broad range of partners (e.g. KOLs, Professional Organizations, Payers, Regulators)
• Align and implement strategy for medical communications and related activities.
• Develop medical strategic plans and ensure consistent execution of outputs through Medical Affairs Teams.
• Provide strategic direction for study design and execution for medical affairs and other global studies.
• Enable access to medicines through clear understanding and education of treatment value.
• Facilitate and continue to build Amgen’s role as a science-based, patient-focused partner.
• Provide input to Value Dossiers.
• Determine resource and budget allocation necessary to deliver on medical strategies.

Collaboration and Coordination:

• Cultivate and improve collaboration and coordination across medical functions.
• Lead/support relationships with the external healthcare community.
• Serve as a medical representative in leadership, governance, and cross-functional teams.

Evidence Generation and Communication:

• Provide insights to Amgen's Safety and Benefit/Risk profile of the molecule.
• Support evidence generation that shapes the therapeutic area and informs the practice of medicine.
• Synthesize and integrate insights to deliver medical inputs into cross-regional/functional strategies.
• Review, approve, and ensure dissemination of medical communications and related activities.
• Lead or support advisory boards and other meetings.

Compliance and Performance:

• Ensure conduct of medical activities in full compliance with all laws, regulations, and SOPs.
• Use global infrastructure for tracking, measuring, and evaluating performance and ensuring continuous performance improvement.

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The ideal candidate we seek is a team player that can adapt easily to a fast-changing environment and possesses the following qualifications:

Basic Qualifications:

MD or DO degree from an accredited medical school OR PhD OR PharmD

AND

2 years of clinical research experience and/or basic science research in obesity and/or cardio-metabolism.

Preferred Qualifications:

• 3 years of clinical research and/or medical affairs experience in a leadership role
• Clinical experience and disease knowledge base in obesity and/or cardio-metabolism
• MD plus accredited fellowship in Cardiology, Endocrinology, Obesity, Internal Medicine or related medical field. Board-certified or board eligible
• Minimum 5 years of Medical Affairs experience in industry (biotech, pharmaceutical or CRO)
• Experience in building Integrated Evidence Generation Plans
• Ability to establish interactions and engagements with partners (e.g., Opinion Leaders, advocacy groups, patients, payers, vendors)
• Familiarity with global regulatory organizations, guidelines, and practices
• Knowledge of Good Clinical Practices (GCP) and global regulations and guidelines
• Knowledge of pharmaceutical product development, product lifecycle, and commercialization processes, including but not limited to, clinical operations, commercial, regulatory, and medical affairs
• History of solving problems while exhibiting sound scientific/medical judgment and a balanced, realistic understanding of issues
• Good understanding of healthcare systems around the world (e.g. US, EU, Asia)
• Track record of success working with matrixed cross-functional teams

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

The annual base salary range for this opportunity in the U.S. is $232,290. - $284,490.

Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

• Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans and bi-annual company-wide shutdowns
• Flexible work models, including remote work arrangements, where possible

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Salary Range