Global Development Lead, Internal Medicine (Sr. Director)
Pfizer
August 13, 2026
Remote friendly (Tampa, FL)
United States
Clinical Research and Development
Responsibilities:
- Lead cross-functional Clinical Development Team for assigned internal medicine asset(s); accountable clinical point for design, execution, interpretation of studies supporting worldwide regulatory submissions.
- Create and gain endorsement for Clinical Development Plan and protocol design documents; partner across study lifecycle.
- Lead/oversee pediatric investigation plan/study plan and protocol design for pediatric feasibility and optimized execution.
- Provide input to target product profiles and regulatory deliverables (e.g., product labels, core data sheets, Investigator Brochures, DSUR, PBRER, Development Safety Update Reports, Periodic Benefit-Risk Evaluation Reports).
- Partner with trial clinicians on governance reviews; provide category strategy and therapy area/indication expertise (CRF design, signal interpretation, AE contextualization).
- Support trial statistical analysis plan (tables/listings/figures, database release) and submission-level deliverables (IAP, IARP, submission TLFs; SCE, SCS, safety narrative plan).
- Support medical monitoring (if required), external stakeholder engagement (Ad boards, Steering Committees, DMC, adjudication committees, patients/advocates), product label development/maintenance, and regulatory disclosure and product defense.
Basic Qualifications / Requirements:
- BS with 12 years or PhD with 7 years relevant clinical/industry experience.
Experience:
- Lead cardiometabolic late-stage development (including type 2 diabetes); track record in academia/biopharma clinical R&D.
- Extensive knowledge of clinical development, global/regional regulation, ICH/GCP, adverse event management.
- Demonstrated clinical/medical, administrative, and project management; effective communication.
- Manage and train large clinical development teams; designing/launching large teams preferred.
Competencies (high level):
- Medical/scientific excellence; matrix leadership and influence; leadership and conflict management; team building; accountability; adaptability.
Other:
- Up to 30% travel may be required.
- Lead cross-functional Clinical Development Team for assigned internal medicine asset(s); accountable clinical point for design, execution, interpretation of studies supporting worldwide regulatory submissions.
- Create and gain endorsement for Clinical Development Plan and protocol design documents; partner across study lifecycle.
- Lead/oversee pediatric investigation plan/study plan and protocol design for pediatric feasibility and optimized execution.
- Provide input to target product profiles and regulatory deliverables (e.g., product labels, core data sheets, Investigator Brochures, DSUR, PBRER, Development Safety Update Reports, Periodic Benefit-Risk Evaluation Reports).
- Partner with trial clinicians on governance reviews; provide category strategy and therapy area/indication expertise (CRF design, signal interpretation, AE contextualization).
- Support trial statistical analysis plan (tables/listings/figures, database release) and submission-level deliverables (IAP, IARP, submission TLFs; SCE, SCS, safety narrative plan).
- Support medical monitoring (if required), external stakeholder engagement (Ad boards, Steering Committees, DMC, adjudication committees, patients/advocates), product label development/maintenance, and regulatory disclosure and product defense.
Basic Qualifications / Requirements:
- BS with 12 years or PhD with 7 years relevant clinical/industry experience.
Experience:
- Lead cardiometabolic late-stage development (including type 2 diabetes); track record in academia/biopharma clinical R&D.
- Extensive knowledge of clinical development, global/regional regulation, ICH/GCP, adverse event management.
- Demonstrated clinical/medical, administrative, and project management; effective communication.
- Manage and train large clinical development teams; designing/launching large teams preferred.
Competencies (high level):
- Medical/scientific excellence; matrix leadership and influence; leadership and conflict management; team building; accountability; adaptability.
Other:
- Up to 30% travel may be required.