Lexeo Therapeutics

Vice President

• Define and lead the global Medical Affairs strategy across Lexeo’s portfolio, ensuring alignment with development milestones and business objectives
• Build, mentor, and lead a high-performing Medical Affairs organization, including external partners and future in-house team members
• Own scientific communications strategy, including publications planning, congress strategy, medical education, and dissemination of clinical and disease-state insights
• Establish and oversee external engagement strategy with key opinion leaders, investigators, medical societies, and patient advocacy organizations
• Serve as the senior Medical Affairs representative in cross-functional governance, partnering with Clinical Development, Regulatory, Market Access, and Patient Advocacy leaders
• Guide medical input into clinical development plans, patient identification strategies, launch readiness planning, and evidence-generation priorities
• Oversee medical review processes and ensure high-quality, compliant externally facing scientific content and response materials
• Lead advisory board strategy and execution, translating stakeholder insights into actionable plans for development and commercialization
• Represent Lexeo externally at major scientific meetings, investigator forums, and executive-level partner interactions
• Drive the development of onboarding, scientific training, and internal medical education initiatives to elevate organizational disease-area expertise
• Lead medical evidence generation and align the same with company objectives

Vice President, Medical Affairs

Clinical Operations

• Collaborate with Lexeo CMO, R&D leadership, Weill Cornell research staff, Lexeo clinical, quality, and regulatory colleagues, CRO partners and other vendors to conduct clinical trials that meet corporate goals
• Evaluate and develop optimal outsourcing model for implementation of trials including selection of CROs and other vendors/ external partners. Oversee development of requests for proposals, negotiate and approve contracts and work orders, and review invoices prior to submission for approval
• Develop, maintain, and report on program budgets, including long-range forecasting, in support of Lexeo’s financial goals
• Monitor study-specific timelines, key deliverables, and implement strategies to optimize the efficiency of trial conduct
• Provide oversight of the CROs to avoid issues or rapidly adapt to challenges of feasibility/start up, slow recruitment, resourcing, site management, etc.

Vice President, Clinical Operations

Clinical Research

• Lead day-to-day management of clinical studies to ensure delivery against timelines, budget, and quality expectations
• Drive study milestones and proactively identify and mitigate risks
• Oversee CROs, laboratories, and vendors to ensure performance aligns with scope, timelines, and budget
• Manage vendor relationships, including scope changes, issue resolution, and ongoing performance oversight
• Partner with internal stakeholders across Clinical, Regulatory, Data Management, and other functions
• Serve as a central operational lead to ensure alignment and efficient study execution
• Contribute to study planning, including timelines, resource plans, budgets, and risk management strategies
• Provide operational input into protocol development, feasibility, and study design
• Act as the primary sponsor contact for study sites
• Oversee site startup and ongoing site management activities
• Ensure proper sample handling, data flow, and protocol adherence
• Ensure compliance with ICH/GCP, FDA regulations, and company SOPs
• Maintain inspection readiness and support audits and regulatory inspections
• Ensure completeness and integrity of the Trial Master File (TMF)
• Author and review study plans, operational documents, and training materials
• Communicate study status, risks, and mitigation plans to stakeholders
• Contribute to process improvements and operational excellence initiatives
• (Sr. CTM) Lead cross-study or departmental initiatives

Clinical Trial Manager – Senior

Director

• 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.

Vice President, Medical Affairs

Vice President, Clinical Operations

Clinical Trial Manager – Senior

Senior Director, Clinical Development