Director/Senior Director, Clinical Development
Lexeo TherapeuticsGene Therapy company
New York, United StatesDirector
D1 Capital Partners
Omega Funds
Eventide Asset Management
Janus Henderson Investors
Longitude Capital
PBM Capital
Leadership & General Management
About the role
TL;DR
Lead clinical development for late-stage programs in rare disease and gene therapy.
- •Lexeo is seeking an experienced clinical development leader to advance late-stage development programs.
- •Key Responsibilities Provide clinical development leadership for assigned programs.
- •Partner with Regulatory, CMC, Quality, Biometrics, Medical Writing, and Clinical Operations.
- •Lead clinical strategy and oversight of protocol development, endpoint selection, eligibility criteria, safety monitoring approach, and clinical rationale.
- •Serve as a clinical leader for investigator and external expert engagement.
- •Drive cross-functional issue resolution and risk management for study execution.
- •Contribute to BLA readiness by ensuring clinical deliverables and timelines are aligned across functions.
- •Lead and/or mentor team members through matrix leadership.
- •Requirements PhD, PharmD, or MD with a minimum of 6 years experience in industry.
- •Proven experience leading late-stage (Phase 2/3 and/or registrational) development for rare disease programs.
- •Demonstrated experience supporting regulatory submission readiness, including BLA filing activities.
- •Thorough knowledge of development program management from IND through NDA/BLA.
- •Experience partnering with Clinical Operations and CROs/vendors to deliver high-quality data and documentation.
- •Advanced working knowledge of relevant guidelines and regulations.
- •Ability to operate effectively in a fast-paced environment.
- •Excellent communication skills and demonstrated ability to influence across multiple functions and levels.
Required skills
Cross-functional Leadership
Domain expertise
healthcare