Director, Global Medical Affairs Lead - Pre-Approval Access
$199,000–$343,000 year
Remote · Raritan, New Jersey, United States
Job Summary
Director, GMAL Pre-Approval Access leads medical and scientific leadership for Oncology Pre-Approval Access programs globally, serving as Study Responsible Physician for PAA activities and supporting select GMAF clinical trials. Responsibilities include medical review of patient eligibility based on protocol criteria, collaboration with GMALs and CDTLs on complex cases, ensuring compliance with SOPs, GCP, and internal policies, and providing medical oversight across PAA and GMAF trials. Requires MD or equivalent, oncology experience, 5+ years in Medical Affairs or clinical research, and willingness to travel up to ~10% with remote-based work. The role emphasizes strategic medical leadership, regulatory alignment, and cross-functional collaboration in a global setting.
Required Qualifications
- MD (or equivalent medical degree) required
- Oncology clinical experience required
- Board certification in Oncology preferred
- Minimum 5 years experience in Medical Affairs or clinical research
- Prior experience as SRP strongly preferred
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