- Oversee activation and management of Expanded Access Programs (EAPs) at treatment centers.
- Lead activities for Post Marketing studies.
- Manage Investigator Sponsored Trials (ISTs) and non-clinical research collaborations.
- Coordinate with Legal for CDAs, clinical trial agreements, and contract amendments.
- Supervise external contract research organizations (CROs) regarding site monitoring and data management.
- Ensure Sunshine Act reporting data collection for lifileucel and Proleukin products.
- Develop and maintain dashboards to communicate study status, progress, and risks.
- Write and update workflows, manuals, and technical documents for clinical programs.