Essential Functions and Responsibilities Oversee the timely activation, execution, and management of Expanded Access Programs (EAPs) that support commercial launch activities at authorized treatment centers Leads the activities for the timely activation, execution, and management of Post Marketing study Oversee the timely activation, execution, and management of ISTs/non-clinical research projects Ensure Sunshine Act reporting data for lifileucel and Proleukin products across Research Alliances programs are collected Works closely with Legal to initiate CDAs, clinical trial and service agreements, amendments and change orders for EAPs, Phase 4, Investigator-Sponsored and non-clinical collaborations. In-depth knowledge of Microsoft Office, including MS Word, MS Excel, MS PowerPoint, and MS Outlook Previous experience with EDC systems (eClinical, Medidata RAVE, InForm), and electronic Trial Master File systems Requires working knowledge of Good Clinical Practices, Food and Drug Administration regulatory reporting requirements, and the regulations and laws governing the pharmaceutical industry (e.g., compliance, Sunshine Act) Preferred Education, Skills, and Knowledge Oncology/immunotherapy experience Phase 4, Expanded Access Program experience The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully.