Clinical Development Executive Medical Director
Pfizer
September 03, 2026
Remote friendly (Cambridge, MA)
United States
Clinical Research and Development
ROLE SUMMARY
This position is for a Clinical Development Executive Medical Director within 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 for Enfortumab vedotin across the Global Development Team, aligned to lifecycle and integrated product plans.
- Own clinical development strategy, trial design, execution, and trial results delivery.
- Integrate regulatory, statistical, and stakeholder input into study designs.
- Lead product-specific Global Development Team; serve as clinical subject matter expert.
- Provide clinical governance support (endorse decisions ahead of reviews/governance).
- Oversee medical director(s); serve as primary interface with the Development Review Committee.
- Oversee clinical protocols/amendments, investigator brochures, and clinical study reports.
- Oversee evaluation, interpretation, reporting, presentation, and publication of study data.
- Accountable for safety decisions and clinical pharmacology input (optimal dose/schedule).
- Lead preparation of clinical content for regulatory submissions (e.g., NDA/MAA/IND/sNDA, IB, AR/DSRU, label changes, Core Data Sheet, Package Insert).
- Provide clinical input for health authority meetings; lead regulator discussions and regulatory query responses.
- Support business development/due diligence via protocol design/conduct/review as appropriate.
BASIC 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 for 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/MAA.
OTHER
- Ability to travel globally as needed; may require work outside typical hours.
- Hybrid work location.
APPLICATION INSTRUCTIONS
Not specified.
This position is for a Clinical Development Executive Medical Director within 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 for Enfortumab vedotin across the Global Development Team, aligned to lifecycle and integrated product plans.
- Own clinical development strategy, trial design, execution, and trial results delivery.
- Integrate regulatory, statistical, and stakeholder input into study designs.
- Lead product-specific Global Development Team; serve as clinical subject matter expert.
- Provide clinical governance support (endorse decisions ahead of reviews/governance).
- Oversee medical director(s); serve as primary interface with the Development Review Committee.
- Oversee clinical protocols/amendments, investigator brochures, and clinical study reports.
- Oversee evaluation, interpretation, reporting, presentation, and publication of study data.
- Accountable for safety decisions and clinical pharmacology input (optimal dose/schedule).
- Lead preparation of clinical content for regulatory submissions (e.g., NDA/MAA/IND/sNDA, IB, AR/DSRU, label changes, Core Data Sheet, Package Insert).
- Provide clinical input for health authority meetings; lead regulator discussions and regulatory query responses.
- Support business development/due diligence via protocol design/conduct/review as appropriate.
BASIC 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 for 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/MAA.
OTHER
- Ability to travel globally as needed; may require work outside typical hours.
- Hybrid work location.
APPLICATION INSTRUCTIONS
Not specified.