Vice President, Head of Clinical Development

Sarepta Therapeutics•Cambridge, MA

4d•Hybrid

About The Position

Why Sarepta? Why Now? The promise of genetic medicine has arrived, and Sarepta is at the forefront. We hold a leadership position in Duchenne muscular dystrophy (Duchenne) and are building a robust portfolio of programs across muscle, central nervous system, and cardiac diseases. In 2023, we launched our fourth therapy and the first ever gene therapy to treat Duchenne. We’re looking for people who see unlimited potential in themselves and who are motivated by an unwavering commitment to patients. What Sarepta Offers At Sarepta, we care deeply about all the people in our community and believe in the importance of supporting them in all aspects of their lives. We aspire to maintain a culture that acknowledges people bring their whole selves to work, and we will strive to help everyone in our community integrate their work and personal lives while maintaining productivity. We are committed to offering a range of benefits and work-life resources designed to support people in the following areas: Physical and Emotional Wellness Financial Wellness Support for Caregivers For a full list of our comprehensive benefits, see our website: https://www.sarepta.com/join-us The Importance of the Role The Vice President, Clinical Development is an enterprise‑level leader responsible for the strategic direction, execution, and accountability of the company’s clinical development portfolio. This leader drives the clinical vision across therapeutic areas, ensuring that programs advance with scientific rigor, regulatory excellence, operational discipline, and cross‑functional alignment. The VP serves as a key advisor to the CMO, a strategic partner to senior leaders across R&D and the broader organization, and a visible representative of the company to external stakeholders including regulatory agencies, investigators, partners, and industry forums. The VP will shape portfolio strategy, ensure high‑quality data generation, anticipate scientific and regulatory challenges, and build a high‑performing clinical development organization. This role requires exceptional leadership, the ability to navigate complexity, and a deep understanding of the full drug development lifecycle from early translational studies through global registration and commercialization. The Opportunity to Make a Difference Strategic Leadership & Vision Define and communicate the long ‑ term vision and strategic direction for Clinical Development, fully aligned with corporate objectives and the CMO's priorities. Provide clinical development leadership and direction across all programs, shaping portfolio strategy, development pathways, risk/benefit assessments, and investment decisions. Anticipate internal and external factors, including scientific trends, competitive landscape, regulatory expectations, and market dynamics that affect clinical strategy. Ensure clinical strategy integrates real‑world evidence, evolving regulatory science, and novel development methodologies where appropriate. Serve as a key member of cross ‑ functional governance bodies (e.g. CSOC and PAC), ensuring clinical perspective informs enterprise decisions. Cross-functional Leadership & Collaboration Partner closely with Development Operations, Biometrics, Regulatory Affairs, Safety, Medical Affairs, CMC, and Commercial to develop integrated development plans and drive program success. Oversee development of clinical components of global regulatory filings, including INDs, CTAs, BLAs/MAAs, briefing packages, and responses to regulatory agencies. Support business development as required by providing clinical review of potential external opportunities and participate in due diligence assessments Facilitate effective decision ‑ making across the portfolio through clear communication of clinical opportunities, risks, timelines, and dependencies. Organizational Leadership & Talent Development Build, mentor, and lead a high ‑ performing Clinical Development organization, fostering a culture of scientific rigor, accountability, and collaboration. Provide executive ‑ level coaching and development for senior clinical leaders (ED/SD/Director levels) to strengthen succession pipelines. Drive organizational excellence initiatives, innovation, and change management efforts to improve efficiency, quality, and scalability. External Engagement Represent the company at scientific, medical, and regulatory meetings, elevating the organization’s reputation and thought leadership in the field. Cultivate strategic partnerships with investigators, academic collaborators, key opinion leaders, advocacy groups, and industry partners. Serve as a senior clinical representative in business development evaluations, diligence activities, and partnership discussions. Financial & Resource Management Own and manage the Clinical Development budget across the portfolio. Ensure optimal allocation of resources to meet corporate goals while balancing risk, timeline, and investment. Oversee vendor and partner evaluations, ensuring the selection and management of high ‑ quality clinical and scientific partners.

Requirements

PhD or MD required.
15+ years of professional experience with 8+ of those years being in progressive leadership roles in clinical development within biotech or pharma.
Extensive experience leading global development programs from early phase through pivotal/registration stages.
Demonstrated success representing clinical development in board ‑ or executive ‑ level settings.
Visionary leadership with the ability to inspire, influence, and align diverse stakeholders.
Deep understanding of clinical development, clinical trial design, and regulatory science.
Exceptional strategic thinking with the ability to balance short‑term execution with long‑term portfolio strategy.
Strong decision‑making capability under uncertainty, with sound scientific judgment.
Excellent communication skills, including the ability to distill complex data for executive audiences.
Demonstrated success driving organizational change, innovation, and operational excellence.
High emotional intelligence, adaptability, and a collaborative leadership style.
Enterprise mindset with strong orientation toward company‑wide impact.
Bias toward action and accountability.
Ability to navigate ambiguity and lead through complexity.
Commitment to patient‑centric development and ethical decision‑making.
Culture builder who champions inclusivity, transparency, and high performance.
Candidates must be authorized to work in the U.S.

Nice To Haves

MD with training or clinical experience in Neurology, Pediatric Neurology, Neuromuscular Medicine, or Medical Genetics strongly preferred.
Subspecialty training or significant clinical research experience in neuromuscular disorders, genetic diseases, or CNS degenerative conditions is highly desirable.
Advanced training or demonstrated expertise in genetic medicines (e.g., gene therapy, RNA/siRNA modalities) is a strong differentiator.
An MBA, MPH, or other advanced degree in clinical research, translational science, or leadership is a plus but not required.
Experience in rare/orphan disease drug development strongly preferred but not required.

Responsibilities

Define and communicate the long ‑ term vision and strategic direction for Clinical Development, fully aligned with corporate objectives and the CMO's priorities.
Provide clinical development leadership and direction across all programs, shaping portfolio strategy, development pathways, risk/benefit assessments, and investment decisions.
Anticipate internal and external factors, including scientific trends, competitive landscape, regulatory expectations, and market dynamics that affect clinical strategy.
Ensure clinical strategy integrates real‑world evidence, evolving regulatory science, and novel development methodologies where appropriate.
Serve as a key member of cross ‑ functional governance bodies (e.g. CSOC and PAC), ensuring clinical perspective informs enterprise decisions.
Partner closely with Development Operations, Biometrics, Regulatory Affairs, Safety, Medical Affairs, CMC, and Commercial to develop integrated development plans and drive program success.
Oversee development of clinical components of global regulatory filings, including INDs, CTAs, BLAs/MAAs, briefing packages, and responses to regulatory agencies.
Support business development as required by providing clinical review of potential external opportunities and participate in due diligence assessments
Facilitate effective decision ‑ making across the portfolio through clear communication of clinical opportunities, risks, timelines, and dependencies.
Build, mentor, and lead a high ‑ performing Clinical Development organization, fostering a culture of scientific rigor, accountability, and collaboration.
Provide executive ‑ level coaching and development for senior clinical leaders (ED/SD/Director levels) to strengthen succession pipelines.
Drive organizational excellence initiatives, innovation, and change management efforts to improve efficiency, quality, and scalability.
Represent the company at scientific, medical, and regulatory meetings, elevating the organization’s reputation and thought leadership in the field.
Cultivate strategic partnerships with investigators, academic collaborators, key opinion leaders, advocacy groups, and industry partners.
Serve as a senior clinical representative in business development evaluations, diligence activities, and partnership discussions.
Own and manage the Clinical Development budget across the portfolio.
Ensure optimal allocation of resources to meet corporate goals while balancing risk, timeline, and investment.
Oversee vendor and partner evaluations, ensuring the selection and management of high ‑ quality clinical and scientific partners.