Manager, Expanded Access Program

Role: Manage global Expanded Access Program (EAP) operations, overseeing vendor performance, compliance, and cross-functional collaboration to facilitate access to investigational products outside clinical trials. Primary objectives include ensuring efficient case management, regulatory adherence, and continuous process improvement. Responsibilities encompass strategic oversight of outsourced vendors, development of operational plans, performance monitoring, and risk management, with a focus on GxP compliance and regulatory standards (FDA, EMA, global). Qualifications: Bachelor's in Life Sciences, Nursing, Pharmacy, or related field; 5–8 years in biotech/pharma, with at least 3 years in clinical or development operations supporting global programs. Experience managing vendors, understanding of expanded access regulations (21 CFR Part 312, EMA frameworks), and cross-functional teamwork are required. Preferred skills include familiarity with Compassionate Use, Right-to-Try, project management, operational metrics development, and regulatory inspections. The role demands strong organizational, analytical, communication, and influence skills in a matrix environment. Location and travel details are not specified.