Director, GMAL - Pre Approval Access SRP
About The Position
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Our Oncology team is focused on the elimination of cancer by discovering new pathways and modalities to finding treatments and cures. We lead where medicine is going and need innovators with an unwavering commitment to results. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. The Director, GMAL Pre‑Approval Access – Study Responsible Physician (SRP) is accountable for providing medical and scientific leadership for Oncology Pre‑Approval Access (PAA) programs globally, serving as the primary Study Responsible Physician for PAA activities. In addition to core PAA responsibilities, this role will assume supplementary SRP responsibilities for select Global Medical Affairs (GMAF) clinical trials, ensuring scientific integrity, operational excellence, and compliance across assigned Medical Affairs studies.
Requirements
- MD (or equivalent medical degree) required
- Oncology clinical experience required
- Minimum 5 years experience in Medical Affairs or clinical research
Nice To Haves
- Board certification in Oncology preferred
- Prior experience as SRP strongly preferred
Responsibilities
- Serve as Study Responsible Physician (SRP) for assigned PAA programs and conduct medical review of individual patient requests.
- Review HCP submissions to determine patient eligibility based on protocol criteria and benefit–risk considerations.
- Partner with GMALs and CDTLs on complex or exceptional eligibility cases.
- Maintain expertise in clinical trial protocols, treatment guidelines, and PAA criteria.
- Collaborate with Post Approval Delivery Unit colleagues to track cases in the Global Trial System.
- Ensure compliance with SOPs, GCP, regulatory requirements, and internal PAA policies.
- Partner with regional Medical Affairs teams to obtain additional clinical context as needed.
- Provide medical and scientific oversight for assigned GMAF-sponsored clinical trials.
- Review and approve study protocols, informed consent forms, and medical review plans.
- Serve as primary medical contact for investigators and internal study teams.
- Support regulatory, safety, and compliance activities.
- Contribute to analysis, interpretation, and dissemination of study results.
- Ensure alignment with the Integrated Evidence Generation Plan (IEGP).
Benefits
- medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
- consolidated retirement plan (pension) and savings plan (401(k)).
- long-term incentive program.
- Vacation – up to 120 hours per calendar year
- Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year
- Holiday pay, including Floating Holidays – up to 13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
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What This Job Offers
Job Type
Full-time
Career Level
Director
