Associate Director, TMF Operations Lead

TMF Operations Lead responsible for developing and executing strategy to ensure completeness, accuracy, and inspection readiness of Trial Master Files across all BBP-418 clinical trials. Responsibilities include leading TMF operations, establishing governance, monitoring quality metrics, overseeing CRO performance, and managing inspection preparedness activities. The role involves process improvement, risk assessment, and fostering TMF excellence in compliance with ICH-GCP and regulatory standards, with a focus on audit support and continuous quality enhancement.

• minimum 8+ years in TMF, Clinical Operations, or Clinical Quality supporting global trials
• strong knowledge of TMF standards, regulatory guidelines, and GxP practices
• excellent organizational, communication, and problem-solving skills
• proficiency in Microsoft Office tools and familiarity with tools like Share Point

• experience with biologics or small molecules in late-stage development
• regulatory inspection support
• cross-functional collaboration

• global clinical trial oversight
• inspection readiness
• focus on compliance with ICH-GCP
• supporting the drug development lifecycle
• potential travel for meetings

remote with travel expectations