Clinical Development Medical Executive Director (Gastrointestinal Cancers)
Responsibilities
- Define and execute oncology development strategy for assigned program(s)/indications; lead clinical development planning aligned to lifecycle/integrated plans.
- Lead or support subteams and/or serve as clinical lead across multiple clinical trials; serve as primary interface with Development Review Committee.
- Act as subject matter expert for clinical issues; endorse clinical decisions with GDPL.
- Oversee trial design/execution and delivery of trial results; integrate regulatory/statistical/stakeholder input into study designs.
- Oversee protocols/amendments, investigator brochures, and clinical study reports; evaluate/interpret/report/present study data.
- Accountable for safety evaluations and safety decisions; coordinate clinical pharmacology for optimal dose/schedule selection.
- Accountable for health authority interactions; escalate to GDPL as needed.
- Lead medical monitoring (eligibility assessment, data review, safety monitoring); lead peer-to-peer investigator interactions; serve as point of contact between study team, investigators, ethics/steering committees, and regulators.
- Lead/contribute to clinical trial and regulatory document development/maintenance.
Qualifications (Basic)
- Medical degree or advanced degree; 5+ years relevant clinical/industry experience.
- 7+ years industry experience; 5+ years leading diverse teams.
- Prior management responsibilities (medical directors/clinical scientists).
- Late-phase drug development experience.
Preferred
- Board certified/eligible in oncology; GI cancer and/or immuno-oncology trial experience.
- Cross-phase oncology drug development; experience leading NDA/BLA/MAA.
Relocation support available. Hybrid role (on-site ~2.5 days/week). Base salary: $295,900β$493,100 plus bonus and long-term incentives; comprehensive benefits including 401(k), leave, and health coverage.