Total 16 job vacancies by Vertex Pharmaceuticals Inc (US)

Job Description

Executive Director/Senior Director, Global Commercial Strategy Pain

Boston, MA (3 days onsite, 2 days remote weekly)

Vertex Pharmaceuticals is seeking a Executive Director or Senior Director of Global Commercial Strategy reporting to the VP Global Commercial Lead for Pain to join our dynamic team in Boston, MA. The candidate will take responsibility for global marketing decisions and tactics that lead Life Cycle Management, portfolio and commercial strategy development whilst supporting the team on successful launches on the pain programs. This will involve shaping global commercial strategy in pain portfolio and developing both strategies and resources to be used by the Regions in their interactions with stakeholders for years to come.  The successful candidate serves as a voice of the community to ensure patients remain at the center of decisions.

The candidate will play a key role in leading the development of the Pain Portfolio strategy.  The role will have a strong focus on Vertex’s outlook in pain across assets, indications and geographies.   This role will integrate launch preparation for ‘Next in class’ molecules with New Product planning.  They will lead development of key deliverables of Pain portfolio strategy including the 3–5 year commercialization strategy. A member of the Early Pipeline team (PT), the coordinating body for the portfolio pipeline in pain, will work closely with cross-functional matrix colleagues to ensure attainment of corporate objectives. The candidate will be the ‘right hand’ to the commercial lead for Pain ensuring aligned commercialization position on pipeline for the Disease Strategy Team and senior leadership. The successful candidate is highly strategic, thrives in an environment of uncertainty and rapid change, demonstrates strong leadership, works effectively within cross-functional teams, and has a problem-solving mindset backed by strong analytical skills. The candidate must share our passion for science-based brands that can dramatically improve patients' lives.

As a senior member on the pain team, the successful candidate must be able to role model Vertex’s ethics & culture and be committed to developing the next generation of leaders.

Key Responsibilities:

• Lead and ensure successful development and implementation of the commercialization (midterm) and portfolio (long term) strategies including brand development, competitive strategy, go-to-market/launch, and lifecycle decisions for future launches. Execute in close partnership with the Regions, Market Access, Regulatory and Commercial Manufacturing.

• Deliver foundational insights about the evolving landscape of pain today and in future, with focus on patients and providers, managing external consultants together with Marketing Science and Market Access

• Execute key global initiatives to prepare the market, enable strong uptake and sustain commercial success.

• Play a key role on the Early PT, integrating commercial position into pain pipeline strategy. There will also be potential to lead ‘Next-in-Class’ PT.

• Support the Global Commercial Team by providing clear direction for the pain portfolio as the primary forum for commercial collaboration and alignment.

• Represent the Commercial team in projects led by others e.g. label development, initiatives, etc.

• Partner with RWE and HEOR to continually evolve our understanding of addressable patient populations, providing input to relevant cross-functional teams (ClinDev, GPMA, HEOR).

• As a senior member of Global Commercial Strategy Pain team they will provide a mentoring/role model to the team.

Qualifications

• Bachelor’s degree required, ideally in life sciences

• Typically requires 12+ years of work experience or the equivalent combination of education and experience  

• In country launch experience, particularly in small molecule/pain, US market experience required and multiple-market experience highly desired.

• Experience in global marketing, new product planning as well as commercial operations or analytics desirable, especially involving product launches.

• Demonstrated ability to work independently and manage initiatives that require collaboration across multiple functional areas.

• An entrepreneurial spirit and an ability to develop creative solutions to complex problems.

• Excellent communication skills

• A solid compliance mindset, demonstrated integrity on the job, embrace of the Vertex Values. 

• Vertex welcomes applicants from diverse backgrounds and promotes an inclusive work-place environment.

#LI-KM3

Company Information

Job Description

General position summary:

The Associate Director, Quality role will work with the GDP Operational QA Management team to ensure that medicines are distributed in the US in compliance with GDP and GMP requirements.  The position will manage the day to day Quality oversight of the Third Party Logistics provider and provide support for key stakeholders within Vertex. 

This Position Reports to: Director, GDP Operational Quality, International QA

Key Accountabilities:

• Serve as the primary contact and have oversight of Distribution and Logistics partners within the US, including:
  • Preparation and maintenance of Quality Agreements
  • Review of deviations, CAPA and changes
  • Maintaining KPIs
  • Analyze, resolve, or assist in solving compliance and customer issues.
  • Escalation of issues
• Remain up to date in GDP and logistics developments and emerging regulations to guide the maintenance of the QMS
• Accountable for New Product Launch activities within the US providing distribution requirements and expectations.
• Working collaboratively with key internal stakeholders

Key Responsibilities:

• Maintain QMS within the Vertex Inc.
• Ensure distribution licences (where required) accurately reflect the current organisation, vary licence where necessary
• Support recalls, mock recalls and any other on-market activity.
• Serve as QA assessor/approver on Change Controls: resolve gaps, approve change plans, classifications, strategy for GDP/GMP actions.
• Support the GDP Management Review process; Review and assess the risk of inputs such as metrics, regulatory intelligence, and identified risks and gaps; Recommend mitigation approaches.
• Participate in expansion activities to ensure that Quality related actions are planned into projects and completed in line with the commitments, e.g. QMS build out, Distribution licences (or equivalent) application, audits, and Quality Agreements.
• Planning/ Preparation/supporting/hosting for Regulatory inspections
• Providing front and backroom inspection support
• Post inspection follow-up with responses and CAPAs (Continuous improvements)
• Manage/Approve/Assess event investigations “deviations” (including Fast Track deviations)
• Manage CAPAs and Effectiveness Checks
• Perform other duties as per GDP guidelines and Vertex policies and procedures
  • Work with Vertex Product Complaints team to ensure that customer complaints are dealt with effectively.
  • Ensure that customers and suppliers are approved
  • Approving any subcontracting activities that may impact GDP.
  • Ensuring that self-inspections are performed at appropriate regular intervals following a prearranged program and necessary corrective measures are put in place.
  • Deciding on the final disposition of returned, rejected, recalled or counterfeit medicines, including the approval of returns to saleable stock.
  • Ensure that any additional requirements imposed on certain products by national law are adhered to.
• Create/review and approve Standard operating Procedures and other Quality Documents

Minimum qualifications:

Master’s degree and 4-5 years of relevant work experience, or Bachelor’s degree in a scientific or allied health field (or equivalent degree) and 9+ years of relevant work experience, or relevant comparable background.

Preferred Qualifications:

• Bachelor's in a scientific or allied health field and relevant GDP & GMP work experience, or relevant comparable background.
• 5+ years’ experience serving in a Quality role.
• Clear understanding to ensure operations do not compromise the quality of products and can demonstrate compliance with GDP.
• Influencing skills in areas with no direct reporting authority.
• Strong interpersonal and communication skills.
• Auditing skills, appropriate qualifications in auditing an advantage.
• Fluency in English is required
• Proficiency in using Microsoft Office applications required (MS Word, MS Excel, MS PowerPoint)

Hybrid-Eligible Roles

In this Hybrid-Eligible role, you can choose to be designated as: 

Hybrid: work remotely up to two days per week; or select

On-Site: work five days per week on-site with ad hoc flexibility.

#LI-Hybrid

Company Information

Job Description

General Summary:

The Quality Systems Director provides technical and strategic leadership for quality systems, quality governance, and quality culture for the cell and gene therapy business unit.  This position focuses not just on the “what” but the “how”, ensuring phase appropriate quality compliance

***This is a hybrid role working 3 days on-site and up to 2 days remotely.**

Key Duties and Responsibilities:

• Monitor and interpret cGMP regulatory guidelines and trends in the breakthrough therapy regulatory space and incorporate into phase appropriate control strategies
• Leads and drives improvements to quality governance forums identifying risks and driving overall compliance and quality maturity
• Provides oversight, support, and drives continuous improvement to quality systems such as change control.  Focuses not just on the process, but the content and compliance of the executed records and helps drive maturity throughout the overall organization.   
• Participates in cross-functional projects in Quality expert and leader role
• Collaborate with internally and external business partners across the organization
• Provides strategies and tactics to address compliance gaps or determines enhancements to improve the overall quality culture of the programs
• As a people manager within the organization, provides leadership, development and coaching to staff, in addition may have financial accountabilities and human resource responsibilities for assigned staff.

Knowledge and Skills:

• Expert knowledge of global GMP requirements governing CGT products
• Ability to evaluate quality matters and make decisions utilizing risk-based approach
• Strong technical knowledge including but not limited to: QMS, risk management, change control and governance.
• Solid quality culture knowledge and understanding of how to influence and improve overall compliance
• Superb facilitation, Communication, and Coaching/influencing skills with proven ability to lead teams
• Experience across multiple GxP areas
• Proven ability to identify and analyze performance indicators.

Education and Experience:

• Bachelor's degree in a scientific discipline, operations research, operations management, or a related field
• Typically requires 10 years of relevant experience and 2 years of supervisor/management experience, or the equivalent combination of education and experience

We’re enabling flexibility and choice between individuals and their managers to maintain our strong culture of collaboration and ensure a daily vibrancy within our sites globally. In this Hybrid, or On-Site-Eligible role, you can choose to work:

In this Hybrid-Eligible role, you can choose to be designated as: 

1. Hybrid: work remotely up to two days per week; or select

2. On-Site: work five days per week on-site with ad hoc flexibility.

#LI-AR1 #LI-Hybrid

Company Information

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

Job Description

Company Information

Job Description

Executive Director, Logistics, Supply Chain Management - Commercial Manufacturing & Supply Chain, Vertex Pharmaceuticals (Boston)

This critical senior position will be responsible for building and leading the Global Logistics Organization within the Commercial Manufacturing and Supply Chain (CMSC) Division. Vertex is rapidly commercializing a pipeline of exciting programs and growing our capabilities to support the supply chain and manufacturing of these therapies. The head of this group will be responsible for defining and delivering the global logistics strategy for commercial therapies and a set of complex pipeline programs.  This strategy includes logistics network design, validation planning and life cycle management for all modalities (small molecule and cell and gene therapies).   The Executive Director will establish logistics as a key strategic pillar to enable successful clinical development and commercialization.

The Executive Director has interaction and impact across multiple Vertex departments and will represent the logistics organization in several executive forums. The Executive Director is responsible for delivering successful product launches across all programs. The Executive Director will cultivate and leverage multiple cross-functional business relationships to deliver a robust logistics strategy.    

This role will report to the VP of Supply Chain Management within the Commercial Manufacturing and Supply Chain (CMSC) division. This supply chain leadership position will be responsible for identifying future capabilities required and building out a high performing, diverse team focusing on developing and implementing a robust logistics strategy and well-controlled operations. The position is based at Vertex’s corporate headquarters in Boston, MA.

Key Responsibilities:

• Define a comprehensive global logistics strategy for a set of diverse pipeline and commercial programs in alignment with Vertex’s corporate strategy.  This strategy includes defining a robust logistics network of global providers to enable successful commercialization.  It also includes a 3-5+ year forward looking assessment of commercial forecast scenarios and associated materials movements to define logistics network expansion and systems requirements.  The role will establish long range optimization strategies to scale and deliver an integrated, best-in-class logistics.    
• Deliver reliable logistics operations, managing thousands of global shipments annually. This operation includes complex and diverse shipments from raw materials through finished goods for small molecules and short lead time, cold chain shipments for cell and gene therapy programs. The operation must deliver reliably for customers with problems being anticipated and mitigated before causing disruption.
• Responsible for defining and tracking global logistics budget.   The Executive Director will partner with Finance to establish the annual logistics budget based on prior year performance and forward-looking forecast.  Once established, the role is accountable for performance within budget and will identify opportunities for cost savings across the logistics network.
• Responsible for proactively assessing risk across logistics operation and developing business continuity plans.   The risk assessment includes couriers, warehouses and lanes for raw materials though finished goods. Risk mitigation and business continuity plans will be delivered to ensure timely, compliant delivery of materials across the supply chain.
• Deliver an integrated inspection readiness and logistics launch plan for Vertex’s Cell and Gene therapy and small molecule programs. The inspection readiness and launch plans include cold chain validation, lane identification, couriers, service level agreements and customer support models. The role will interact with multiple contract manufacturers, warehouses and couriers to train, onboard and successfully launch. The role will also include integration of systems requirements and complicated short-lead time cold chain logistics.  The Executive Director is responsible for leading the team through inspection and launch readiness, including making risk-based decisions to enable program success.
• Drive excellence in end-to-end operations through identification and management of key supply chain KPI’s.  Establish service level agreements and KPI’s throughout network.  Monitor KPI’s, deviation rates and performance across a complex network of providers. Drive operational efficiency, flawless execution and continuous improvement across the supply chain to deliver a best-in-class logistics organization. 
• Build a high performing team including forward looking organizational design requirements to scale to meet Vertex’s future vision.   Foster team culture, build trust and establish clear roles and responsibilities.
• Maintain an external network to stay updated on industry trends, emerging technologies and best practices in logistics.
• Champion the culture of quality and ensure that all activities and documentation comply with global regulatory requirements. Understand and implement processes and controls that align with GDP, evolving Health Authority, import/export and other regulatory expectations.  

Minimal Requirements:

• 12-15+ years progressive experience in supply chain, logistics and/or manufacturing leadership roles in the pharmaceutical industry. Experience with Biological products and Genetic and Cell Therapy technologies is strongly preferred.
• Experience in building and managing a complex global supply chain logistics operation.
• The candidate is expected to be a thought leader in logistics and supply chain and have a proven ability to innovate and implement practical, compliant solutions.
• A proven ability to work seamlessly across teams and develop excellent partnerships with peers.
• Demonstrated understanding of the principles and regulations associated with GDP operations.
• A results-oriented leader with a sense of urgency to deliver quality results in a highly ethical and professional manner.
• Motivational leadership of a cohesive high-performing team within a global, matrixed environment; the ability to articulate vision and successfully drive execution.
• Excellent communication and interpersonal skills with the ability to communicate complex issues and solutions enterprise-wide.
• Excellent team player who is able to build and sustain respect and trust at all levels of the organization.
• Ability to anticipate adverse scenarios and provide contingency plans to address them.
• Sound judgment and business acumen with personal versatility and flexibility as the business and team evolves.

Company Information

Job Description

Company Information

Job Description

General Summary:

The Associate Director, Modeling & Simulation will combine strong pharmacometric skills with deep biological understanding to independently determine, plan, and execute M&S analyses in close collaboration with cross-functional colleagues within the R&D organization. This incumbent determines, plans, and executes technically challenging analyses by using state of the art Modeling & Simulation methodologies to strongly contribute to critical decision making. The incumbent will lead M&S projects to evaluate study design, dose selection, probability of success estimation, portfolio strategy, pediatric extrapolation, etc. The incumbent will represent M&S with cross-functional drug development teams and clearly communicate M&S results. Finally, the incumbent will have general management duties, including possible oversight of managers and professionals, and/or management of a team(s).

Key Duties and Responsibilities:

• Independently develops M&S analysis plans in alignment with an asset strategy, determines relevant outcomes, executes, and interprets multiple modeling analyses
• Perform mechanism-based PKPD and population PK and PK/PD analyses, clinical trial simulations, translational modeling (preclinical – clinical) and other model-based analyses and in collaboration with other scientists on a regular basis
• With significant independence, perform dataset construction, evaluation and interpretation of results, and pre- and post-processing activities including informative graphics creation
• Represents M&S on cross-functional drug development teams
• Serves as the M&S lead on pharmacometric deliverables for a study, including population PK, PKPD, exposure-response, model-based meta-analysis, trial simulation, etc.
• Participates in preparation of regulatory responses

Knowledge and Skills:

• Possess specialized, in-depth experience in M&S and excellent research record in the area of M&S, such as design and analysis of nonlinear mixed models, dynamic models, mechanistic models, adaptive designs with respect to model fitting, estimation, optimization, in particular differential equation dynamic modeling.
• Deep understanding of biology, pharmacokinetic and quantitative pharmacology (PKPD) principles.
• Advanced skills with the use of NONMEM PsN, R, and similar tools
• Excellent collaborative, leadership, verbal and written communication skills

Education and Experience:

• Master's or PhD, with preference in Pharmaceutical sciences, Pharmacometrics, mathematics, statistics, or other quantitative discipline with an emphasis on Pharmacometrics and PKPD modeling
• Typically requires the following: PhD and 6 years experience or Master's Degree and 10 years of experience in the application of Pharmacometric and other Modeling methodologies in the context of drug research & development in industry, academia or regulatory agencies.

Pay Range 156,000.00 – 234,000.00 USD annually

The range provided is based on what we believe is a reasonable estimate for the base salary   pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.

At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility   and resources to support their growth and aspirations.  From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.

#LI-AR1 #LI-Remote

Company Information

Job Description

Vertex is seeking a talented individual to join our US Pain Business Unit to support our journey to bring forth new options for the treatment of pain. The  Digital Patient Marketing Associate Director, US Pain will own digital patient activation in an acute market responsible for creating and executing digital marketing strategies to reach and engage patients in support of the Pain disease area, which is preparing for potential commercialization of an investigational novel selective inhibitor of NaV1.8 in acute pain. This role will support the evolution and implementation of our innovative go to market model, supporting the launch with focus on empowering patients in treatment discussions and simplifying the patient journey. We are seeking a candidate with extensive experience with digital marketing, non-personal promotion, demonstrated success leading complex cross-functional and agency workstreams and the ability to drive stakeholder alignment across various levels. The successful candidate will have the ability to thrive in a fast-paced, innovation-focused environment. This role will report to the Director of Patient Marketing for the US Pain Business Unit.

For more information about Vertex’s pain program, visit https://www.vrtx.com/research-development/pipeline/pain/. To learn more about working at Vertex and our commitment to a vibrant and inclusive culture, visit https://www.vrtx.com/working-here/inclusion-diversity-equity/

Key Responsibilities

• This role is responsible for developing digital patient engagement programs, in line with Patient Marketing priorities
• Will lead the Patient branded media strategy and development of the patient media plan including selection of media programs
• Will collaborate closely with the Director of Digital Customer Engagement and product owner team on patient journey mapping and execution of media plans
• Will work with information technology, multiple vendors, and agencies to ensure the organization's processes, budget, and platforms are operating effectively to support the commercial business needs
• Translate the brand strategy into an effective launch tactical plan for patient digital promotion through creation and execution of measurable programs that engage patient at multiple touchpoints throughout their treatment journey and takes into consideration the different patient segments
• Direct and manage agencies of record to create all digital programming materials such as digital media, social media, SEO/SEM, CRM efforts, and automated engagement tactics ensuring external partners remain on-time and on-budget
• Continuously scan and evaluates external digital patient pilot partnership opportunities to support new patient digital capability building
• Closely partner with Regulatory/Legal/Medical review committee to obtain approval for effective and compliant marketing materials
• Establish key performance indicators for materials to measure and ensure effectiveness of their impact and return on investment
• Partner with privacy and legal on ensuring compliance aligned to emerging state regulations related to healthcare data

Required Education And Experience

• Bachelor's degree in relevant discipline
• Typically requires 8+ years of work experience leading the delivery of customer facing digital non-personal promotional programs to promote products and services to external customers, or the equivalent combination of education and experience

​

Required Skills

• In-depth knowledge of non-personal digital promotional capabilities
• Ability to effectively communicate compelling digital marketing concepts and complex ideas to cross-functional audiences at all levels of the organization
• Experience managing complex internal and external partner relationships involving creative, digital, and media agencies
• Expertise in measurement and analytics of digital programs
• Strong understanding of web content management processes and platforms
• Strategic thinking and strong analytical skills
• Detail orientation and strong organization, prioritization and project management skills, with demonstrated ability to manage multiple tasks
• Demonstrated understanding of the legal, regulatory, and compliance requirements for pre-and post-approval activities
• An entrepreneurial spirit and an ability to develop creative solutions to complex problems
• Aligned with company culture focused on ethics and integrity in all we do
• Comfortable working in a highly collaborative and results-driven environment within a growing business unit where we are concurrently learning & building as we drive towards product launch

Travel requirements

• Ability to travel 25-30% - include cross-country
• This position is a hybrid position based in Boston

#LI-KM3

Company Information

Job Description

Vertex is seeking a talented individual to join our US Pain Business Unit to support our journey to bring forth new options for the treatment of pain. The Digital HCP Marketing Associate Director, US Pain will own digital non-personal promotion and Healthcare Provider (HCP) activation in an acute care market responsible for creating and executing digital marketing strategies to reach and engage diverse HCP specialties (surgeons, anesthesiologists,  internists, NP/PA, pharmacists, nurses, etc.) across multiple settings of care (Hospital, Ambulatory Surgical Center (ASC), Office-Based) in support of the Pain Management disease area, which is preparing for potential commercialization of an investigational novel selective inhibitor of NaV1.8 in acute pain. This role will support the evolution and implementation of our innovative go to market model, supporting the launch with focus on educating and equipping HCPs across acute settings of care to consider effective and innovative non-opioid options for their patients with acute pain. We are seeking a candidate with extensive experience with digital non-personal promotion, demonstrated success leading complex cross-functional and agency workstreams and the ability to drive stakeholder alignment across various levels. The successful candidate will have the ability to thrive in a fast-paced, innovation-focused environment. This role will report to the Director of HCP Marketing for the US Pain Business Unit.

For more information about Vertex’s pain program, visit https://www.vrtx.com/research-development/pipeline/pain/. To learn more about working at Vertex and our commitment to a vibrant and inclusive culture, visit https://www.vrtx.com/working-here/inclusion-diversity-equity/

Key Responsibilities

• This role is responsible for developing digital HCP engagement programs that support the goals and objectives of the overall brand strategy of the Pain Marketing Team
• Lead development of HCP branded non-personal promotional strategy and plan including selection of media programs
• Collaborate closely with Director of Digital Customer Engagement and product owner team on HCP journey mapping and execution of non-personal promotional media plans
• Work with information technology, multiple vendors, and agencies to ensure the organization's processes, budget, and platforms are operating effectively to support the commercial business needs
• Translates the brand strategy into an effective launch tactical plan for HCP NPP through creation and execution of measurable programs that engage HCPs across multiple settings of care (Hospital Inpatient, Hospital Outpatient, ASC and Office-Based) with messaging and education that is relevant to their current needs in managing their patient’s acute pain.
• Direct and manage agencies of record to create all digital programming materials:
  • Manage agencies to deliver annual digital plan and execute all tactics on time and within budget
  • Drive creation and delivery of digital content and assets for HCP media, social media channels and other digital channels of interest
  • Establish promotional campaigns including CRM and automated engagement
• Closely partner with Regulatory/Legal/Medical review committee to obtain approval for effective and compliant HCP marketing materials
• Establish key performance indicators for key materials to measure and ensure effectiveness of their impact and return on investment
• Establishes and maintains a strong team understanding of the external digital landscape (including trends in AI)

Required Education And Experience

• Bachelor's degree in relevant discipline
• Typically requires 8+ years of work experience leading the delivery of customer facing digital non-personal promotional programs to promote products and services to external HCP customers, or the equivalent combination of education and experience

​

Required Skills

• In-depth knowledge of HCP non-personal digital promotional capabilities
• Ability to effectively communicate compelling digital marketing concepts and complex ideas to cross-functional audiences at all levels of the organization
• Experience managing complex internal and external partner relationships involving creative, digital, and media agencies
• Expertise in measurement and analytics of digital programs
• Strong understanding of web content management processes and platforms
• Strategic thinking and strong analytical skills
• Detail orientation and strong organization, prioritization and project management skills, with demonstrated ability to manage multiple tasks
• Demonstrated understanding of the legal, regulatory, and compliance requirements for pre-and post-approval activities
• An entrepreneurial spirit and an ability to develop creative solutions to complex problems
• Aligned with company culture focused on ethics and integrity in all we do
• Comfortable working in a highly collaborative and results-driven environment within a growing business unit where we are concurrently learning & building as we drive towards product launch

​

Travel requirements

• Ability to travel 25-30% - include cross-country
• This position is a hybrid position weekly (3 days onsite, 2 days remote) based in Boston

#LI-KM3

Company Information

Job Description

General Summary:

The Quality Compliance Director provides strategic leadership for quality culture, inspection readiness, clinical to commercial transition, and escalation process for the cell and gene therapy business unit.  The role has specific focus on external and internal manufacturing/testing inspection readiness and ongoing compliance to changing regulatory expectations.  This position focuses not just on the “what” but the “how”, ensuring phase appropriate quality compliance. 

***This is a hybrid role working 3 days on-site and up to 2 days remotely.**

Key Duties and Responsibilities:

• Provides tactics to address compliance gaps or determines enhancements to improve the overall quality culture of the programs
• Leads inspection and compliance programs both internally and externally.  Works cross-functionally across many different functional areas and programs. 
• Provide leadership, strategic thinking, and mentorship to staff, focusing on employee development and leadership skills
• Leads and manages complex projects/teams within corporate objectives and project timelines
• Monitor and interpret cGMP regulatory guidelines and trends in the breakthrough therapy regulatory space and incorporate into inspection readiness and control strategies
• Collaborate with internally and external business partners to resolve complex quality issues to ensure compliant solutions
• Be directly involved in and where appropriate, lead multiple process/product improvement projects which may include quality system process improvements, development of new methodologies and improving existing methodologies, data generation, report development and presentation
• As a people manager within the organization, may have financial accountabilities and human resource responsibilities for assigned staff.

Knowledge and Skills:

• Expert knowledge of global GMP requirements governing CGT products

  • Superb facilitation, Communication, and Coaching/influencing skills with proven ability to lead teams

  • Ability to evaluate quality matters and make decisions utilizing risk-based approach

  • Solid quality culture knowledge and understanding of how to influence and improve overall compliance

  • Strong presentation skills and ability to influence others

  • Proven ability to identify and analyze performance indicators.

Education and Experience:

• Bachelor's degree in a scientific discipline, operations research, operations management, or a related field
• Typically requires 10 years of relevant experience and 2 years of supervisor/management experience, or the equivalent combination of education and experience

We’re enabling flexibility and choice between individuals and their managers to maintain our strong culture of collaboration and ensure a daily vibrancy within our sites globally. In this Hybrid, or On-Site-Eligible role, you can choose to work:

In this Hybrid-Eligible role, you can choose to be designated as: 

1. Hybrid: work remotely up to two days per week; or select

2. On-Site: work five days per week on-site with ad hoc flexibility.

#LI-AR1 #LI-Hybrid

Company Information

Job Description

General/Position Summary

The Senior Director, Quality be responsible for the oversight of Product Quality/ External Manufacturing of Cell & Gene Programs.  The role will be responsible for supporting the commercial transition of the Cell & Gene quality  strategy to meet business, regulatory and operational requirements.

The is a critical role within Quality department responsible for managing CDMO partnerships to ensure that the company effectively and efficiently delivers medicines to patients. This role is also directly responsible for co-leading joint project teams with CDMO’s.

This position will be based in Vertex’s corporate headquarters in Boston, MA. This role will partner closely with operational stakeholders to ensure seamless supply of all clinical and commercial products and to lead/support the development and execution of quality projects.   The senior director of quality will also participate in Cell & Genetic therapies projects and governance committees covering external manufacturing. 

**This is a hybrid role working 3 days on-site and up to two days remotely.**

Key Duties & Responsibilities

• Establishment of quality oversight for external CMO operations.
• Prioritize, develop and implement systems, processes and tools to ensure that the systems, processes and resourcing are optimal for transition from development through product life cycle and set up to scale efficiently and effectively.
• Ensure appropriate metrics and tracking are in place for operational monitoring and as early key indicators for operational issues.
• Represent Quality in Cell & Gene Programs and serve as a trusted advisor and partner to establish the CMC quality strategy and roadmap for innovative therapeutic programs.
• Support GxP Cell & Gene Therapy Management Reviews to gain insights regarding efficiency and operational performance across the GXP operations, including identification of opportunities for improvement and associated actions.
• Provides quality leadership and partner with operational stakeholders to ensure efficient operations and mitigation of risks. Support/lead risk management activities, including identification of gaps, implementation of mitigation plans and associated execution.
• Provide significant CDMO-focused regulatory filing input (IND, BLA, etc) and drive operations-focused pre-approval inspection and commercial readiness activities at the CDMOs.  Adjudicate compliance discussions, and negotiate any required corrective actions.
• Represent C&G Quality to lead/participate in complex projects and partner with key stakeholders for alignment in strategic and operational planning and delivery of business & financial priorities and goals.
• Create and foster a culture of collaboration, development, and engagement for advancing quality outcomes and operational excellence.
• Lead and mentor other team members, support development of organizational capabilities and talent building.

Required Education Level

• Bachelor’s and Master's degree in a Scientific/Technical/Business discipline.

Required Experience

• 15+ years of experience and 7+ years in a management/supervisory role, or the equivalent combination of education and experience in a regulated pharmaceutical environment

Required Knowledge/Skills

• Experienced in quality assurance operations role  for a allogeneic/autologous cell manufacturing process.
• In-depth global health regulatory agency knowledge and experience across GXP life cycle in Cell & Gene therapy and/or Biologics.
• Demonstrated strategic planning and execution skills required for operational effectiveness and compliance.
• Broad technical knowledge in Cell technology, aseptic manufacturing technology, analytical assays, cell & genetic therapies/Biologics processing, fill/finish and testing.
• Current knowledge of industry trends and best practices in Cell/Gene therapies.
• Operational Excellence experience with proven ability to lead improvement projects-Experience with Root Cause Analysis, data analytics, and other Operational Excellence experience, such as LEAN, DMAIC, Six Sigma.
• Excellent communication skills and a proven track record Influencing/building/promoting a culture of Quality and Excellence.
• Ability to apply risk management principles to decision making and operational priorities.
• Critical Thinking and Problem Solving skills

Other Requirements
 

15% travel

Hybrid role in Boston, MA

We’re enabling flexibility and choice between individuals and their managers to maintain our strong culture of collaboration and ensure a daily vibrancy within our sites globally. In this Hybrid, or On-Site-Eligible role, you can choose to work:

In this Hybrid-Eligible role, you can choose to be designated as: 

1. Hybrid: work remotely up to two days per week; or select

2. On-Site: work five days per week on-site with ad hoc flexibility.

#LI-AR1 #LI-Hybrid

Company Information

Job Description

Vertex operates at the forefront of scientific innovation and has successfully developed and commercialized multiple breakthrough medicines for Cystic Fibrosis (CF) as well as Casgevy, a new gene therapy for sickle cell disease and beta-thalassemia.  Vertex has more than a dozen ongoing research programs focused on the underlying mechanisms of other serious diseases including programs in Pain, APOL-1 mediated kidney disease (AMKD), and cell therapies for Type 1 diabetes, among others.   

In consideration of our expanding pipeline and an increasingly complex and challenging Global market access environment, Vertex is expanding its Global Value and Access Strategy (GVAS) team.  Market Access is a key commercial function that ensures transformative Vertex therapies are appropriately funded and ultimately make it into the hands of the patients around the world.  The GVAS team works cross-functionally and across regions to ensure the payer view is represented in commercial and development plans across the lifecycle.  We are driven by a desire to deliver groundbreaking pricing & reimbursement solutions to allow our medicines to reach patients faster than ever before.  

The Director, GVAS role will serve as Market Access Lead for the chronic indications of our Pain portfolio, a series of novel non-opioid analgesics that have the potential to reshape the pain market. The individual will be responsible for leading the development of Global Market Access strategies, as well as co-lead the Global Commercial Team for chronic indications across the Vertex Pain portfolio.  The role reports to Sr Director, Pain Portfolio lead.  

Key Responsibilities:

• Responsible for Global payer strategic planning to support value and access optimization for chronic indications for our Pain portfolio
  • Lead development of Market Access strategies and core Global P&R deliverables operating within the cross-functional, cross-regional commercialization process
    • Responsible for Global payer strategic planning to support value and access optimization; lead development of Global Payer Plan which integrates value evidence generation, strategic pricing, value communications, stakeholder engagement to support successful reimbursement and pricing
  • Accountable for ensuring the market access and payer perspective is reflected in cross-functional strategies (e.g. commercial, product development, regulatory affairs)
  • Ensure evidence prioritization required to capture value, support a differentiated target product profile (TPP), and ensure local pricing and access
  • Support strategies with deep functional knowledge, in-depth market research, environmental data & analogs
  • Inform financial forecasts
  • Partner with Health Economics & Outcomes Research (HEOR), Real-World Evidence (RWE) and Global Marketing to ensure robust value proposition and integrated evidence plans are optimized to support global market access and reimbursement
• Co-lead Global Commercial Teams, and work cross-functionally and cross-regionally to develop optimal commercial strategies
  • The Global Commercial Team facilitates development of a commercial strategy in order to maximize the lifetime value of the asset globally; is the primary hub for alignment and input into the Disease Strategy Team
  • This role should ensure collaboration and drive alignment across Global Commercial Team and leadership to integrate market access strategy and ensure resourcing for commercial success
• Support P&MA capability building and thought leadership projects that advance knowledge of and readiness for the rapidly evolving Global payer environment
• Maintain industry awareness and proactively address changes in market trends, competition, product acceptance and new product releases and adjust Market Access plans accordingly
• Collaborate closely with HEOR, International P&R, Corporate Affairs, US Market Access, Countries, Marketing and Clinical Development counterparts to ensure value and access optimization

Qualifications:

• 8+ years of direct biotechnology / pharmaceutical industry experience and/or payer experience
• Deep working knowledge of both US and ex-US healthcare systems required; experience in comparable Global role considered a plus
• Experience in leading cross-functional teams required
• Experience in specialty and/or rare disease access models preferred
• Demonstrated ability to think strategically and make sound pricing and market access recommendations
• Entrepreneurial, energetic, dynamic, enthusiastic, decisive, and self-motivated; possesses a sense of urgency with the ability and strong desire to "make things happen"
• Strong practical, quantitative and analytical skills combined with a sound understanding of how to successfully apply pricing & reimbursement / HEOR principles to support Vertex
• General experience in commercialization and drug development
• Exhibits outstanding written and oral communication skills, including the ability to effectively write and deliver presentations to professionals at all levels within Vertex
• Demonstrated relationship building at all levels of the organization and across geographies
• Recognized as a team player with excellent interpersonal skills who is flexible and reliable
• Displays sound ethics and a fit for Vertex’s core values

Education:

• BA/BS in field of study requiring quantitative analysis; advanced degree preferred

#LI-LN1

Company Information