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Director/Senior Director, Clinical Development

Lexeo Therapeutics

Lexeo Therapeuticslexeotherapeutics.com

Director/Senior Director, Clinical Development

Posted 2 months ago

This job is still taking applications, but it's been up a while.

About the job

Lexeo Therapeutics, based in NYC, focuses on genetic medicines for inherited cardiovascular diseases. The role involves leading clinical strategies for late-stage programs, supporting regulatory submissions, and mentoring teams to deliver high-quality evidence.

Requirements

  • PhD, PharmD, or MD with 5-6 years experience
  • Experience leading late-stage development
  • Supported regulatory submission readiness
  • Knowledge of IND through BLA processes
  • Partnered with CROs and vendors

Qualifications

  • Strong communication skills
  • Ability to operate in fast-paced environment
  • Knowledge of ICH, GCP, FDA guidelines
  • Leadership and mentoring ability
  • Experience in rare disease programs

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.




    • About Lexeo


    Lexeo Therapeutics is a clinical-stage genetic medicine company headquartered in New York City, pioneering cardiac genetic medicine candidates to treat the root causes of inherited cardiovascular diseases. Our lead program, LX2006, targets cardiomyopathy associated with Friedreich’s Ataxia and anchors a broader pipeline addressing genetically defined conditions such as hypertrophic and arrhythmogenic cardiomyopathies. Backed by a strong financial foundation, Lexeo is positioned to translate groundbreaking science into durable clinical impact.

    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.




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