Global Development Lead, Internal Medicine (MD, Sr. Director)
Pfizer
September 02, 2026
Remote friendly (Lake Forest, IL)
United States
Clinical Research and Development
Role Summary
The Global Development Lead (GDL) represents Clinical on the Global Medicine Team and is the single clinical point of accountability for clinical development for assigned asset(s) in Internal Medicine. Leads cross-functional Clinical Development Teams in the design, execution and interpretation of studies supporting worldwide regulatory submissions. Accountable for creating and gaining endorsement for the Clinical Development Plan and associated protocol design documents.
Responsibilities
- Partner with the Medicine Team Lead to negotiate tradeoffs, milestones, timelines, and budget.
- Create comprehensive clinical development plans globally (including China and Japan), including pediatric investigation/study plans and protocol design documents.
- Provide product/program input for target product profile(s).
- Bring innovative thinking and bold decision-making across programs and studies.
- Develop clinical development enabling strategies (digital/innovation and patient engagement).
- Partner with trial clinicians on governance reviews; provide category strategy input.
- Provide therapy area/indication expertise for clinical data review (CRF design, signal interpretation, AE contextualization).
- Support trial-level statistical analysis plan, TLFs/table-listings-figures, and database release with statistics/programming.
- Develop submission deliverables (IAP, IARP, submission TLFs) including SCE and SCS; review/approve submission-level safety narrative plan.
- Support product label development and maintenance.
- Engage external stakeholders (e.g., advisory boards, steering committees, DMC, adjudication committees, patients/patient advocates).
- Provide regulatory submission support (DSUR, PBRER) including disclosure deliverables and product defense.
- Ensure compliance with internal SOPs and external regulatory standards.
Basic Qualifications
- MD or DO.
- Cardiologist (strongly preferred) with cardiovascular outcome trials or large complex global development programs.
- 8+ years relevant experience in clinical research and development.
- Extensive knowledge of clinical development, global/regional regulation, ICH/GCP, and adverse event management.
- Demonstrated clinical/medical, administrative, and project management capability; strong verbal and written communication.
- Demonstrated experience managing/training large teams; designing/launching large teams preferred.
Competency Requirements (high level)
- Clinical/scientific excellence, management in matrix environments, leadership and influencing.
- Conflict management, team building, accountability, and agility in change.
Non-standard work
- Up to 30% travel.
- Relocation support available.
- Hybrid: live within commuting distance; work on-site ~2.5 days/week.
Application instructions
Not provided in the text.
The Global Development Lead (GDL) represents Clinical on the Global Medicine Team and is the single clinical point of accountability for clinical development for assigned asset(s) in Internal Medicine. Leads cross-functional Clinical Development Teams in the design, execution and interpretation of studies supporting worldwide regulatory submissions. Accountable for creating and gaining endorsement for the Clinical Development Plan and associated protocol design documents.
Responsibilities
- Partner with the Medicine Team Lead to negotiate tradeoffs, milestones, timelines, and budget.
- Create comprehensive clinical development plans globally (including China and Japan), including pediatric investigation/study plans and protocol design documents.
- Provide product/program input for target product profile(s).
- Bring innovative thinking and bold decision-making across programs and studies.
- Develop clinical development enabling strategies (digital/innovation and patient engagement).
- Partner with trial clinicians on governance reviews; provide category strategy input.
- Provide therapy area/indication expertise for clinical data review (CRF design, signal interpretation, AE contextualization).
- Support trial-level statistical analysis plan, TLFs/table-listings-figures, and database release with statistics/programming.
- Develop submission deliverables (IAP, IARP, submission TLFs) including SCE and SCS; review/approve submission-level safety narrative plan.
- Support product label development and maintenance.
- Engage external stakeholders (e.g., advisory boards, steering committees, DMC, adjudication committees, patients/patient advocates).
- Provide regulatory submission support (DSUR, PBRER) including disclosure deliverables and product defense.
- Ensure compliance with internal SOPs and external regulatory standards.
Basic Qualifications
- MD or DO.
- Cardiologist (strongly preferred) with cardiovascular outcome trials or large complex global development programs.
- 8+ years relevant experience in clinical research and development.
- Extensive knowledge of clinical development, global/regional regulation, ICH/GCP, and adverse event management.
- Demonstrated clinical/medical, administrative, and project management capability; strong verbal and written communication.
- Demonstrated experience managing/training large teams; designing/launching large teams preferred.
Competency Requirements (high level)
- Clinical/scientific excellence, management in matrix environments, leadership and influencing.
- Conflict management, team building, accountability, and agility in change.
Non-standard work
- Up to 30% travel.
- Relocation support available.
- Hybrid: live within commuting distance; work on-site ~2.5 days/week.
Application instructions
Not provided in the text.