Global Development Lead, Internal Medicine (Sr. Director)
Pfizer
August 13, 2026
Remote friendly (Bothell, WA)
United States
Clinical Research and Development
Responsibilities:
- Serve as single clinical point of accountability for assigned asset(s); lead cross-functional Clinical Development Team (clinical, clinical pharmacology, statistics, safety, commercial, patient access, operations).
- Create and gain endorsement for Clinical Development Plan and protocol design documents; partner across study lifecycle.
- Lead regulatory submission efforts and contribute to submission deliverables (e.g., SCE, SCS, clinical overview); support target product profile input and regulatory activities (labels, core data sheets, Investigator Brochures, DSUR, PBRER, Development Safety Update Reports, Periodic Benefit-Risk Evaluation Reports).
- Provide therapy area/indication expertise for CRF design, signal interpretation, and adverse-event contextualization; provide specialized medical monitoring support if required.
- Partner on trial-level statistical analysis plan, TLFs, and database release; develop submission-level deliverables (IAP, IARP, submission TLFs) and submission safety narrative plan.
- Support label development/maintenance; engage external stakeholders (ad boards, steering committees, DMC, adjudication committees, patients/advocates).
- Ensure compliance with internal SOPs and external regulatory standards; review IIR proposals.
Basic Qualifications:
- BS with 12 years or PhD with 7 years relevant clinical/industry experience.
Experience:
- Lead cardiometabolic late-stage development (incl. type 2 diabetes).
- Track record in clinical R&D (academia and/or biopharma).
- Deep knowledge of clinical development, global/regional regulation, ICH/GCP, adverse event management.
- Demonstrated leadership of large clinical teams; strong communication and project management.
Other requirements/skills:
- Proven ability to influence in a matrix environment; innovative, bold decision-making; strong governance/conflict management.
Benefits/Comp (as stated):
- Eligible for Global Performance Plan bonus (22.5% target) and long-term incentive; comprehensive benefits incl. 401(k) match, paid leave, and medical/dental/vision.
Application instructions:
- Not provided in the excerpt.
- Serve as single clinical point of accountability for assigned asset(s); lead cross-functional Clinical Development Team (clinical, clinical pharmacology, statistics, safety, commercial, patient access, operations).
- Create and gain endorsement for Clinical Development Plan and protocol design documents; partner across study lifecycle.
- Lead regulatory submission efforts and contribute to submission deliverables (e.g., SCE, SCS, clinical overview); support target product profile input and regulatory activities (labels, core data sheets, Investigator Brochures, DSUR, PBRER, Development Safety Update Reports, Periodic Benefit-Risk Evaluation Reports).
- Provide therapy area/indication expertise for CRF design, signal interpretation, and adverse-event contextualization; provide specialized medical monitoring support if required.
- Partner on trial-level statistical analysis plan, TLFs, and database release; develop submission-level deliverables (IAP, IARP, submission TLFs) and submission safety narrative plan.
- Support label development/maintenance; engage external stakeholders (ad boards, steering committees, DMC, adjudication committees, patients/advocates).
- Ensure compliance with internal SOPs and external regulatory standards; review IIR proposals.
Basic Qualifications:
- BS with 12 years or PhD with 7 years relevant clinical/industry experience.
Experience:
- Lead cardiometabolic late-stage development (incl. type 2 diabetes).
- Track record in clinical R&D (academia and/or biopharma).
- Deep knowledge of clinical development, global/regional regulation, ICH/GCP, adverse event management.
- Demonstrated leadership of large clinical teams; strong communication and project management.
Other requirements/skills:
- Proven ability to influence in a matrix environment; innovative, bold decision-making; strong governance/conflict management.
Benefits/Comp (as stated):
- Eligible for Global Performance Plan bonus (22.5% target) and long-term incentive; comprehensive benefits incl. 401(k) match, paid leave, and medical/dental/vision.
Application instructions:
- Not provided in the excerpt.