Executive Leadership & Board
Chief Development Officer
Own development from registrational cohort to BLA for an AAV gene therapy in a rare neuromuscular disease. Clinical, regulatory, CMC and program management report into this role.
A typical mandate
The company develops AAV-based gene therapies for rare neuromuscular diseases. Its lead program holds RMAT designation and is enrolling a registrational cohort, with a second program in IND-enabling studies. The CEO is bringing development under one leader ahead of a planned BLA.
What the role owns
- Lead clinical development, regulatory affairs, CMC and program management as one integrated function
- Own the integrated development plan and BLA timeline for the lead program
- Lead FDA interactions on potency assays, comparability and accelerated approval
- Make resourcing and sequencing decisions across the pipeline with the CEO and CFO
- Represent development to the board, investors and patient advocacy groups
- Build a leadership bench that can scale into commercial readiness
What great candidates bring
- MD, PhD or PharmD with 15+ years in drug development and at least 5 years at executive level
- Hands-on experience taking a cell or gene therapy through late-stage development
- Direct BLA experience, ideally including a CBER review
- Sound judgment on CMC risk, including AAV manufacturing, potency and comparability
- Experience with expedited pathways such as RMAT, Breakthrough Therapy or accelerated approval
- A record of leading senior functional heads and building trust across functions
Why it matters
- Executive committee role reporting to the CEO
- Equity and long-term incentives aligned with the BLA and launch
- Direct impact on a therapy for patients with very few options
- Hybrid schedule, with flexibility around travel
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