Global Development Lead, Internal Medicine (MD, Sr. Director)
Pfizer
September 03, 2026
Remote friendly (Lake Forest, IL)
United States
Clinical Research and Development
Role Summary
- Lead clinical development accountability for assigned Internal Medicine assets; represent Clinical on the Global Medicine Team.
- Lead cross-functional Clinical Development Team (clinical, clinical pharmacology, statistics, safety, commercial, patient access, operations) to design, execute, and interpret studies for worldwide regulatory submissions.
- Create and gain endorsement for Clinical Development Plan and protocol design documents; partner across study lifecycle and as needed with external companies.
- May assume additional clinical leadership for Obesity portfolio (late-stage trial design, execution, reporting).
Responsibilities
- Partner with Medicine Team Lead to negotiate tradeoffs, milestones, and deliver clinical program on timeline/budget.
- Own comprehensive global clinical development plan (incl. China/Japan), pediatric investigation/study plan, and protocol design docs.
- Provide input to target product profiles; drive innovative decision-making; develop digital/innovation and patient engagement enabling strategies.
- Support governance reviews with trial clinicians; provide therapy-area expertise (CRF design, signal interpretation, adverse event contextualization).
- Support trial-level statistical analysis plan, TLF/table-listings-figures, and database release.
- Develop submission deliverables (IAP, IARP, submission TLFs), including SCE and SCS; interpret and communicate clinical data.
- Review/approve submission safety narrative plan; support product label development/maintenance.
- Engage external stakeholders (ad boards, steering committees, DMC, adjudication committees, patients/patient advocates).
- Provide regulatory submission support (DSUR, PBRER) and product defense; ensure compliance with SOPs and regulatory standards.
Basic Qualifications
- MD or DO.
- Endocrinologist or internal medicine physician with cardiometabolic late-stage development experience including type 2 diabetes.
- 8+ years clinical R&D experience; knowledge of clinical development, global/regional regulation, ICH/GCP, adverse event management.
- Proven clinical/medical, administrative, and project management; strong written/verbal communication; experience managing/training large clinical development teams (designing/launching large teams preferred).
Competencies
- Medical/scientific credibility; management in complex matrix; leadership, influencing, conflict management, team building, accountability, and agility.
Travel/Environment
- Up to 30% travel; hybrid role (on-site ~2.5 days/week, commute distance required).
- Lead clinical development accountability for assigned Internal Medicine assets; represent Clinical on the Global Medicine Team.
- Lead cross-functional Clinical Development Team (clinical, clinical pharmacology, statistics, safety, commercial, patient access, operations) to design, execute, and interpret studies for worldwide regulatory submissions.
- Create and gain endorsement for Clinical Development Plan and protocol design documents; partner across study lifecycle and as needed with external companies.
- May assume additional clinical leadership for Obesity portfolio (late-stage trial design, execution, reporting).
Responsibilities
- Partner with Medicine Team Lead to negotiate tradeoffs, milestones, and deliver clinical program on timeline/budget.
- Own comprehensive global clinical development plan (incl. China/Japan), pediatric investigation/study plan, and protocol design docs.
- Provide input to target product profiles; drive innovative decision-making; develop digital/innovation and patient engagement enabling strategies.
- Support governance reviews with trial clinicians; provide therapy-area expertise (CRF design, signal interpretation, adverse event contextualization).
- Support trial-level statistical analysis plan, TLF/table-listings-figures, and database release.
- Develop submission deliverables (IAP, IARP, submission TLFs), including SCE and SCS; interpret and communicate clinical data.
- Review/approve submission safety narrative plan; support product label development/maintenance.
- Engage external stakeholders (ad boards, steering committees, DMC, adjudication committees, patients/patient advocates).
- Provide regulatory submission support (DSUR, PBRER) and product defense; ensure compliance with SOPs and regulatory standards.
Basic Qualifications
- MD or DO.
- Endocrinologist or internal medicine physician with cardiometabolic late-stage development experience including type 2 diabetes.
- 8+ years clinical R&D experience; knowledge of clinical development, global/regional regulation, ICH/GCP, adverse event management.
- Proven clinical/medical, administrative, and project management; strong written/verbal communication; experience managing/training large clinical development teams (designing/launching large teams preferred).
Competencies
- Medical/scientific credibility; management in complex matrix; leadership, influencing, conflict management, team building, accountability, and agility.
Travel/Environment
- Up to 30% travel; hybrid role (on-site ~2.5 days/week, commute distance required).