Sarepta Therapeutics · 14 hours ago
Vice President, Head of Clinical Development
Cambridge, MA
Full-time
Hybrid
Director/Executive
$346K/yr - $432K/yr
15+ years expSarepta Therapeutics is a leader in genetic medicine, particularly in Duchenne muscular dystrophy, and is seeking a Vice President, Head of Clinical Development. This role involves strategic leadership in clinical development, overseeing the execution of the clinical portfolio, and ensuring high-quality data generation while collaborating with various departments and external stakeholders.
BiotechnologyGeneticsHealth CareTherapeutics
No H1B
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
Qualification
Required
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
Preferred
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
Benefits
Physical and Emotional Wellness
Financial Wellness
Support for Caregivers
Company
Sarepta Therapeutics
Sarepta Therapeutics focuses on the discovery and development of precision genetic medicine to treat rare diseases.
501-1000 employees
Funding
Current Stage
Public CompanyTotal Funding
$2.88BKey Investors
Michael Andrew ChambersPharmakon AdvisorsMidCap Financial
2025-12-11Post Ipo Debt· $291.4M
2025-08-21Post Ipo Equity
2025-08-21Post Ipo Debt· $602M
Leadership Team
Ian Estepan
Executive Vice President, Chief Financial Officer
K
Kathy Behrens Wilsey
Director
Recent News
2026-01-24
Genetic Engineering News
2026-01-23
Company data provided by crunchbase