PhD, PharmD, or MD with 5-6 years of experience in biotechnology or pharmaceuticals.
Experience leading Phase 2/3 registrational trials for rare disease programs.
Background in regulatory submission processes, particularly BLA filings.
Knowledge of development program management from IND to NDA/BLA including inspection readiness.
Experience collaborating with Clinical Operations and CROs for quality data and documentation delivery.
Strong understanding of ICH, GCP, and FDA regulations and guidelines.
Proven ability to thrive in a fast-paced environment with changing priorities.
Responsibilities
Provide leadership for late-stage clinical development programs in rare disease and gene therapy.
Collaborate with various departments to create an integrated development plan for BLA strategy.
Lead the clinical strategy including protocol development and safety monitoring.
Engage with investigators and KOLs to boost study enrollment and ensure quality conduct.
Manage cross-functional issues and risks for study execution, maintaining documentation and quality standards.
Ensure alignment of clinical deliverables and timelines in preparation for BLA readiness.
Mentor team members and foster a culture of collaboration and scientific rigor.
Benefits
Hybrid work model with 2 days in the New York office and 3 days remote.
Opportunity to be part of a pioneering company in cardiac genetic medicine.
A chance to work on innovative therapies targeting inherited cardiovascular diseases.
Full 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, 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 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 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.
$247,500 - $382,000 a year
Compensation is dependent on qualifications and experience
Our work culture is a hybrid model with 2 days/week in the New York City office and 3 days working from home.
