Director/Senior Director, Clinical Development

Lexeo Therapeutics, Inc.; New York (NY); Hybride; USD 250 000 - 350 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Leadership

Cross-functional collaboration

Regulatory submission readiness

Communication

Formation

PhD, PharmD, or MD

Description du poste

Role Summary

Lexeo is seeking an experienced and motivated clinical development leader to advance late-stage development programs as a key member of our development team. This individual will report to the Vice President, Clinical Development, Cardiology and will provide strategic and hands‑on leadership across clinical strategy, study execution, and cross‑functional integration to deliver high‑quality evidence to support regulatory interactions and submissions (e.g., BLA). This role requires strong scientific and operational judgement and the ability to build effective partnerships with internal stakeholders and external collaborators.

Primary Responsibilities

• Provide clinical development leadership for assigned programs, including late-stage (Phase 2/3 and/or registrational) studies in rare disease and gene therapy.
• Partner with Regulatory, CMC, Quality, Biometrics, Medical Writing, and Clinical Operations to shape an integrated development plan aligned with program objectives and BLA strategy.
• Lead clinical strategy and oversight of protocol development, endpoint selection, eligibility criteria, safety monitoring approach, and clinical rationale to support health authority interactions.
• Serve as a clinical leader for investigator and external expert engagement, including KOL interactions, advisory boards (as applicable), and site relationships to support enrollment and high‑quality study conduct.
• Drive cross-functional issue resolution and risk management for study execution; ensure decisions are documented and aligned with quality standards and inspection readiness.
• Contribute to BLA readiness by ensuring clinical deliverables and timelines are aligned across functions (e.g., CSR strategy, data review readiness, and clinical modules inputs).
• Lead and/or mentor team members through matrix leadership; support a culture of accountability, collaboration, and scientific rigor.

Required Skills and Qualifications

• PhD, PharmD, or MD with a minimum of 6 years experience in industry ( 8 years for Senior Director ), including 5 - 6 years of progressive experience within clinical development and late-stage trial delivery.
• 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 (e.g., clinical deliverables coordination, inspection readiness support, and cross‑functional alignment).
• Thorough knowledge of development program management from IND through NDA/BLA, including audit/inspection readiness.
• Experience partnering with Clinical Operations and CROs/vendors to deliver high‑quality data and documentation, including milestone management, budget awareness, and reporting/CSR support.
• Advanced working knowledge of relevant guidelines and regulations (including ICH, GCP, and FDA requirements).
• Ability to operate effectively in a fast‑paced environment with shifting priorities and timelines.
• Excellent communication skills and demonstrated ability to influence across multiple functions and levels, internally and externally.

About Lexeo

Lexeo Therapeutics is a New York City-based, clinical stage company dedicated to reshaping the path of genetic disease. By advancing pioneering science, Lexeo seeks to set a new standard in the treatment of cardiovascular and neurological genetic diseases, charting the path to patient outcomes once thought out of reach. The Company is advancing a portfolio of therapeutic candidates designed to address the underlying genetic causes of disease, including LX2006 for Friedreich ataxia (FA), LX2020 for plakophilin-2 (PKP2) arrhythmogenic cardiomyopathy, and others in devastating diseases with high unmet need.

Our work culture is a hybrid model with 2 days/week in the New York City office and 3 days working from home.

Lexeo Therapeutics is an EEO employer committed to an exciting, diverse, and enriching work environment.