Director/Senior Director, Clinical Development

Lexeo Therapeutics; New York (NY); On-site; USD 275,000 - 348,000; Full time

Job summary

Lexeo Therapeutics in New York is seeking an experienced clinical development leader to guide late-stage development programs. This role requires expertise in regulatory submission readiness and late-stage trial delivery. Candidates should have a PhD, PharmD, or MD with at least 5 years' industry experience, and demonstrate strong leadership and communication skills. The salary range for this position is $275,000 to $348,000 annually, dependent on qualifications and experience.

Qualifications

• 5-6 years of progressive experience in biotechnology or pharmaceutical clinical development.
• Experience leading late-stage development for rare disease programs.
• Knowledge of ICH, GCP, and FDA guidelines.

Responsibilities

• Provide clinical development leadership for assigned programs.
• Partner with Regulatory, Quality, and Clinical Operations.
• Lead oversight of protocol development and clinical rationale.
• Drive cross-functional issue resolution for study execution.
• Ensure clinical deliverables and timelines are aligned.

Skills

Clinical development leadership

Regulatory submission readiness

Cross-functional collaboration

Excellent communication skills

Ability to influence

Education

PhD, PharmD, or MD

Job description

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 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 judgment 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 5-6 years of progressive experience in the biotechnology or pharmaceutical industry 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.

$275,000 - $348,000 a year

Compensation is dependent on qualifications and experience

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