Clinical Development Executive Medical Director
Pfizer
September 03, 2026
Remote friendly (Pennsylvania, United States)
United States
Clinical Research and Development
Role Responsibilities
- Lead, develop, and execute the clinical development plan for Enfortumab vedotin 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 the product-specific Global Development Team; serve as clinical subject matter expert.
- Endorse clinical development decisions prior to GPT/senior management/governance reviews.
- Provide oversight/management for 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.
- Own safety decisions and clinical pharmacology for optimal dose/schedule selection.
- Lead clinical content preparation for regulatory submissions/documents (e.g., NDA/MAA/IND/sNDA, IB, AR/DSRU, label/Core Data Sheet/Package Insert).
- Provide clinical input for meetings with health authorities and regulatory query responses.
- Support business development initiatives as appropriate (e.g., due diligence protocol design/conduct/review).
Basic Qualifications
- Medical degree or advanced degree with relevant clinical/industry experience (typically 4+ years).
- 7+ years industry experience.
- 5+ years experience 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, or MAA.
Other
- Ability to travel globally as needed; may work outside typical hours.
- Individual contributor or management responsibility for 1–6 Associate Medical Directors/Medical Directors/Senior Medical Directors.
- Reports to Therapeutic Area Head.
- Lead, develop, and execute the clinical development plan for Enfortumab vedotin 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 the product-specific Global Development Team; serve as clinical subject matter expert.
- Endorse clinical development decisions prior to GPT/senior management/governance reviews.
- Provide oversight/management for 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.
- Own safety decisions and clinical pharmacology for optimal dose/schedule selection.
- Lead clinical content preparation for regulatory submissions/documents (e.g., NDA/MAA/IND/sNDA, IB, AR/DSRU, label/Core Data Sheet/Package Insert).
- Provide clinical input for meetings with health authorities and regulatory query responses.
- Support business development initiatives as appropriate (e.g., due diligence protocol design/conduct/review).
Basic Qualifications
- Medical degree or advanced degree with relevant clinical/industry experience (typically 4+ years).
- 7+ years industry experience.
- 5+ years experience 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, or MAA.
Other
- Ability to travel globally as needed; may work outside typical hours.
- Individual contributor or management responsibility for 1–6 Associate Medical Directors/Medical Directors/Senior Medical Directors.
- Reports to Therapeutic Area Head.