Global Development Lead, Internal Medicine (MD, Sr. Director)
Pfizer
August 11, 2026
Remote friendly (La Jolla, CA)
United States
Clinical Research and Development
Role Summary
- Lead cross-functional Clinical Development for assigned Internal Medicine asset(s), serving as the single clinical point of accountability for study design, execution, and interpretation supporting worldwide regulatory submissions.
- Create and gain endorsement for the Clinical Development Plan and associated protocol design documents; act as key partner throughout study lifecycle.
- Provide/lead clinical leadership for additional late-stage Obesity portfolio opportunities as needed.
Responsibilities
- Negotiate clinical program tradeoffs, milestones; ensure delivery in line with timelines and budget.
- Own comprehensive global clinical development plan (incl. China/Japan), plus pediatric investigation/study plan and protocol documents.
- Provide product/program input for target product profiles; drive innovative, bold decisions across studies.
- Develop clinical development enabling strategies (digital/innovation, patient engagement).
- Partner with trial clinicians on governance reviews and provide category strategy input.
- Provide therapy area expertise for CRF design, signal interpretation, and adverse event contextualization.
- Provide medical monitoring support if required.
- Partner on trial-level SAPs, TLFs/table-listings-figures, and database releases.
- Develop submission deliverables (IAP, IARP, submission TLFs); lead submission deliverables including SCE and SCS; review/approve submission safety narrative plan.
- Support clinical data interpretation and communication; support product label development/maintenance.
- Engage external stakeholders (ad boards, Steering Committees, DMC, adjudication committees, patients/advocates) to support clinical strategy and PDD development.
- Provide regulatory submission support (DSUR, PBRER) and product defense; ensure compliance with internal SOPs and external regulatory standards.
- Review IIR proposals.
Basic Qualifications
- MD or DO.
- Cardiologist (strongly preferred) with cardiovascular outcome trials or large complex global programs.
- 8+ years clinical R&D experience (academia and/or biopharma).
- Extensive knowledge: clinical development, global/regional regulation, ICH/GCP, adverse event management.
Competency Requirements
- Medical/scientific credibility; coordinate/execute clinical development or lifecycle strategy.
- Management and leadership in complex matrix environments; influence/collaborate and motivate teams.
Travel/Environment
- Up to 30% travel; hybrid (on-site ~2.5 days/week).
Benefits/Application Instructions
- Not provided in the supplied job-description body.
- Lead cross-functional Clinical Development for assigned Internal Medicine asset(s), serving as the single clinical point of accountability for study design, execution, and interpretation supporting worldwide regulatory submissions.
- Create and gain endorsement for the Clinical Development Plan and associated protocol design documents; act as key partner throughout study lifecycle.
- Provide/lead clinical leadership for additional late-stage Obesity portfolio opportunities as needed.
Responsibilities
- Negotiate clinical program tradeoffs, milestones; ensure delivery in line with timelines and budget.
- Own comprehensive global clinical development plan (incl. China/Japan), plus pediatric investigation/study plan and protocol documents.
- Provide product/program input for target product profiles; drive innovative, bold decisions across studies.
- Develop clinical development enabling strategies (digital/innovation, patient engagement).
- Partner with trial clinicians on governance reviews and provide category strategy input.
- Provide therapy area expertise for CRF design, signal interpretation, and adverse event contextualization.
- Provide medical monitoring support if required.
- Partner on trial-level SAPs, TLFs/table-listings-figures, and database releases.
- Develop submission deliverables (IAP, IARP, submission TLFs); lead submission deliverables including SCE and SCS; review/approve submission safety narrative plan.
- Support clinical data interpretation and communication; support product label development/maintenance.
- Engage external stakeholders (ad boards, Steering Committees, DMC, adjudication committees, patients/advocates) to support clinical strategy and PDD development.
- Provide regulatory submission support (DSUR, PBRER) and product defense; ensure compliance with internal SOPs and external regulatory standards.
- Review IIR proposals.
Basic Qualifications
- MD or DO.
- Cardiologist (strongly preferred) with cardiovascular outcome trials or large complex global programs.
- 8+ years clinical R&D experience (academia and/or biopharma).
- Extensive knowledge: clinical development, global/regional regulation, ICH/GCP, adverse event management.
Competency Requirements
- Medical/scientific credibility; coordinate/execute clinical development or lifecycle strategy.
- Management and leadership in complex matrix environments; influence/collaborate and motivate teams.
Travel/Environment
- Up to 30% travel; hybrid (on-site ~2.5 days/week).
Benefits/Application Instructions
- Not provided in the supplied job-description body.