Vice President, Head of Clinical Development

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profile Job Location:

Cambridge, MA - USA

profile Yearly Salary: $ 346000 - 432500
Posted on: Yesterday
Vacancies: 1 Vacancy

Job Summary

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 2023 we launched our fourth therapy and the first ever gene therapy to treat Duchenne.

Were 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: Importance of the Role

The Vice President Clinical Development is an enterpriselevel leader responsible for the strategic direction execution and accountability of the companys clinical development portfolio. This leader drives the clinical vision across therapeutic areas ensuring that programs advance with scientific rigor regulatory excellence operational discipline and crossfunctional 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 highquality data generation anticipate scientific and regulatory challenges and build a highperforming 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 longterm vision and strategic direction for Clinical Development fully aligned with corporate objectives and the CMOs 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 realworld evidence evolving regulatory science and novel development methodologies where appropriate.

  • Serve as a key member of crossfunctional 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 decisionmaking across the portfolio through clear communication of clinical opportunities risks timelines and dependencies.

Organizational Leadership & Talent Development

  • Build mentor and lead a highperforming Clinical Development organization fostering a culture of scientific rigor accountability and collaboration.

  • Provide executivelevel 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 organizations 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 highquality clinical and scientific partners.

More about You

Education

  • PhD or MD required. 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

  • 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 executivelevel settings.

  • Experience in rare/orphan disease drug development strongly preferred but not required.

Skills & Competencies

  • 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 shortterm execution with longterm portfolio strategy.

  • Strong decisionmaking 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.

Leadership Attributes

  • Enterprise mindset with strong orientation toward companywide impact.

  • Bias toward action and accountability.

  • Ability to navigate ambiguity and lead through complexity.

  • Commitment to patientcentric development and ethical decisionmaking.

  • Culture builder who champions inclusivity transparency and high performance.

What Now

Were always looking for solution-oriented critical thinkers.

So if youre comfortable with ambiguity and candor relish challenging yourself and place kindness and integrity at the forefront of how you approach your peers and work then we encourage you to apply.

#LI-Hybrid

#LI-CM1

This position is hybrid you will be expected to work on site at one of Sareptas facilities in the United States and/or attend Company-sponsored in-person events from time to time.

The targeted salary range for this position is $346000 - $432500 per year. Sarepta is making a good faith effort to be transparent and accurate around our hiring ranges. The salary offer is commensurate with Sareptas compensation philosophy and considers factors including but not limited to education training experience external market conditions criticality of role and internal equity.

Candidates must be authorized to work in the U.S.

Sarepta Therapeutics offers a competitive compensation and benefit package.

Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.

Required Experience:

Exec

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 2023 we launched our fourth thera...
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Key Skills

  • Change Management
  • Financial Services
  • Growing Experience
  • Managed Care
  • Management Experience
  • Analysis Skills
  • Senior Leadership
  • Performance Management
  • Process Management
  • Leadership Experience
  • negotiation
  • Analytics

About Company

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We are focused on the development of precision genetic medicines to treat rare neuromuscular and central nervous system diseases. Learn more about Sarepta.

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