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Lexeo Therapeutics

Posted 2 months ago

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Vice President, Clinical Operations

New York, New YorkOn-siteFull-time

AI Summary

Leads and builds the Clinical Operations function, overseeing clinical trials for gene therapies to meet on-time and on-budget goals, collaborating with CMO, R&D, CROs, and regulatory teams.

About this role

Role Summary

Lexeo is seeking an experienced and motivated professional to lead and build our Clinical Operations function as a key member of our development team. This individual will report to the Chief Medical Officer and will ensure that studies are completed on time and within budget in accordance with corporate objectives. This is a hands-on role and will be required to build excellent working relationships with various internal and external groups.

If you enjoy being a part of a growing team and an entrepreneurial environment in which your work will have a meaningful impact on clinical trial progress for novel gene therapies, we want to hear from you!

Primary Responsibilities

  • 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.

    • Required Skills and Qualifications

  • Advanced degree preferred and 10+ years of experience in the pharmaceutical or biotech industry within clinical operations and trial management
  • Experience leading global clinical trials; rare disease/gene therapy trial experience preferred
  • Thorough knowledge of development program management from IND- through NDA/BLA, including inspection readiness
  • Extensive experience in CRO/ vendor selection and oversight, budget projection and management, establishing clear milestones, ensuring high-quality data delivery and report generation
  • Advanced working knowledge of all relevant guidelines, including ICH, GCP, FDA
  • Experience working in a fast-paced environment
  • Excellent communication skills and ability to influence across multiple functions

    • Skills

    BLABudget ManagementClinical OperationsClinical Trial ManagementCRO SelectionGCPICHINDNDAProject Management

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