Job Description

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