Strategic Director, Late-Stage Clinical Development

Lexeo Therapeutics, Inc.; New York (NY); Hybrid; USD 250,000 - 350,000; Full time

Job summary

Lexeo Therapeutics, Inc. seeks an experienced clinical development leader to advance late-stage programs and drive strategic and hands-on execution across study design, operations, and regulatory readiness.

Reporting to the Vice President, Clinical Development, Cardiology, this role shapes development plans, leads protocol and endpoint decisions, mentors teams, and fosters collaboration with internal functions and external partners to deliver high-quality evidence for regulatory interactions

Qualifications

• Requires advanced clinical development leadership for late-stage programs.
• Experience coordinating regulatory submissions and interactions (e.g., BLA).
• Strong communication and influencing across multiple functions.

Responsibilities

• Provide clinical development leadership for late-stage, rare disease and gene therapy programs.
• Partner with Regulatory, CMC, Quality, Biometrics, Medical Writing and Clinical Operations.
• Lead protocol development, endpoint selection and safety monitoring strategies.
• Engage with investigators, KOLs and external experts to support enrollment.
• Ensure issue resolution and risk management aligned with quality standards.
• Contribute to BLA readiness with timelines and CSR strategy.

Skills

Leadership

Cross-functional collaboration

Regulatory submission readiness

Communication

Education

PhD, PharmD, or MD

Job description

Lexeo Therapeutics, Inc. seeks an experienced clinical development leader to advance late-stage programs and drive strategic and hands-on execution across study design, operations, and regulatory readiness.

Reporting to the Vice President, Clinical Development, Cardiology, this role shapes development plans, leads protocol and endpoint decisions, mentors teams, and fosters collaboration with internal functions and external partners to deliver high-quality evidence for regulatory interactions