Clinical Development Executive Medical Director
Pfizer
September 03, 2026
Remote friendly (New York, NY)
United States
Clinical Research and Development
ROLE SUMMARY
Clinical Development Executive Medical Director for the GU Therapeutic Area responsible for defining and executing the development strategy of Enfortumab vedotin.
ROLE RESPONSIBILITIES
- Lead, develop, and execute the clinical development plan in alignment with the Lifecycle Management Plan and Integrated Product Plan.
- Own clinical development strategy, trial design, execution, and delivery of trial results.
- Integrate regulatory, statistical, and stakeholder input into study designs.
- Lead product-specific Global Development Team.
- Serve as clinical subject matter expert; endorse clinical development decisions in advance of review/governance bodies.
- Provide oversight/management of medical director(s).
- Primary interface with the Development Review Committee.
- Oversee protocols/amendments, investigator brochures, and clinical study reports.
- Oversee evaluation, interpretation, reporting, presentation, and publication of study data.
- Accountable for safety decisions and clinical evaluations.
- Accountable with clinical pharmacology for optimal dose and schedule selection.
- Lead clinical content for regulatory submissions/documents (e.g., NDA/MAA/IND, IB, label changes, Core Data Sheet, Package Insert).
- Provide clinical input to health authority meetings and regulatory query responses.
- Support business development; may design/conduct/review protocols for due diligence.
QUALIFICATIONS
- Medical degree or advanced degree with relevant clinical/industry experience (typically 4+ years).
- 7+ years industry experience.
- 5+ years leading diverse teams.
- Prior management responsibilities of medical directors or clinical scientists.
PREFERRED QUALIFICATIONS
- Board certified/eligible in oncology (or equivalent).
- Experience across multiple clinical phases and oncology drug classes.
- Experience leading NDA, BLA, or MAA.
NON-STANDARD WORK/TRAVEL
- Ability to travel globally as needed; may work outside typical hours.
OTHER
- Individual contributor or may manage 1–6 Associate Medical Directors/Medical Directors/Senior Medical Directors.
Clinical Development Executive Medical Director for the GU Therapeutic Area responsible for defining and executing the development strategy of Enfortumab vedotin.
ROLE RESPONSIBILITIES
- Lead, develop, and execute the clinical development plan in alignment with the Lifecycle Management Plan and Integrated Product Plan.
- Own clinical development strategy, trial design, execution, and delivery of trial results.
- Integrate regulatory, statistical, and stakeholder input into study designs.
- Lead product-specific Global Development Team.
- Serve as clinical subject matter expert; endorse clinical development decisions in advance of review/governance bodies.
- Provide oversight/management of medical director(s).
- Primary interface with the Development Review Committee.
- Oversee protocols/amendments, investigator brochures, and clinical study reports.
- Oversee evaluation, interpretation, reporting, presentation, and publication of study data.
- Accountable for safety decisions and clinical evaluations.
- Accountable with clinical pharmacology for optimal dose and schedule selection.
- Lead clinical content for regulatory submissions/documents (e.g., NDA/MAA/IND, IB, label changes, Core Data Sheet, Package Insert).
- Provide clinical input to health authority meetings and regulatory query responses.
- Support business development; may design/conduct/review protocols for due diligence.
QUALIFICATIONS
- Medical degree or advanced degree with relevant clinical/industry experience (typically 4+ years).
- 7+ years industry experience.
- 5+ years leading diverse teams.
- Prior management responsibilities of medical directors or clinical scientists.
PREFERRED QUALIFICATIONS
- Board certified/eligible in oncology (or equivalent).
- Experience across multiple clinical phases and oncology drug classes.
- Experience leading NDA, BLA, or MAA.
NON-STANDARD WORK/TRAVEL
- Ability to travel globally as needed; may work outside typical hours.
OTHER
- Individual contributor or may manage 1–6 Associate Medical Directors/Medical Directors/Senior Medical Directors.