Global Development Lead, Internal Medicine (Sr. Director)
Pfizer
August 13, 2026
Remote friendly (La Jolla, CA)
United States
Clinical Research and Development
Responsibilities:
- Lead cross-functional Clinical Development Team to design, execute, and interpret studies for worldwide regulatory submissions.
- Create and gain endorsement for the Clinical Development Plan and associated protocol design documents; partner with trial clinicians across study lifecycle.
- Lead development planning for approval and reimbursement globally (incl. China/Japan), including pediatric investigation plan/study plan and pediatric protocol documents.
- Provide therapy area/indication expertise (CRF design, signal interpretation, adverse event contextualization) and input to target product profiles.
- Develop clinical development enabling strategies (digital/innovation, patient engagement).
- Partner in governance reviews; contribute category clinical development strategy input.
- Support trial-level statistical analysis plan, TLFs, table-listings-figures, and database release (with statistics/programming).
- Develop submission-level deliverables (IAP, IARP, submission TLFs) including SCE and SCS; support label development/maintenance.
- Lead/review submission safety narrative plan; provide regulatory submission support (DSUR, PBRER) and product defense.
- Engage external stakeholders (e.g., ad boards, steering committees, DMC, adjudication committees, patients).
- Ensure compliance with internal SOPs and external regulatory standards.
Basic Qualifications:
- BS with 12+ years or PhD with 7+ years relevant clinical/industry experience.
Experience:
- Lead cardiometabolic late-stage programs (incl. type 2 diabetes).
- Track record of success in academia and/or biopharma clinical R&D.
- Knowledge of global/regional regulation, ICH/GCP, adverse event management.
- Manage/train large clinical teams; experience designing/launching large teams preferred.
Key Skills/Competencies (required):
- Medical/scientific excellence; strong management and leadership in matrix environments.
- Effective influencing, conflict management, team building, accountability, and agility in uncertainty.
Non-standard/Env:
- Up to 30% travel; hybrid (on-site ~2.5 days/week). Relocation support available.
Compensation/Benefits (if hired):
- Base salary range: $214,900–$358,100 (U.S. range; Tampa, FL differs). Bonus target 22.5% of base; participation in share-based long-term incentives; 401(k) match; paid vacation/holidays; caregiver/parental and medical leave; medical/dental/vision coverage.
Application instructions: None stated in provided text.
- Lead cross-functional Clinical Development Team to design, execute, and interpret studies for worldwide regulatory submissions.
- Create and gain endorsement for the Clinical Development Plan and associated protocol design documents; partner with trial clinicians across study lifecycle.
- Lead development planning for approval and reimbursement globally (incl. China/Japan), including pediatric investigation plan/study plan and pediatric protocol documents.
- Provide therapy area/indication expertise (CRF design, signal interpretation, adverse event contextualization) and input to target product profiles.
- Develop clinical development enabling strategies (digital/innovation, patient engagement).
- Partner in governance reviews; contribute category clinical development strategy input.
- Support trial-level statistical analysis plan, TLFs, table-listings-figures, and database release (with statistics/programming).
- Develop submission-level deliverables (IAP, IARP, submission TLFs) including SCE and SCS; support label development/maintenance.
- Lead/review submission safety narrative plan; provide regulatory submission support (DSUR, PBRER) and product defense.
- Engage external stakeholders (e.g., ad boards, steering committees, DMC, adjudication committees, patients).
- Ensure compliance with internal SOPs and external regulatory standards.
Basic Qualifications:
- BS with 12+ years or PhD with 7+ years relevant clinical/industry experience.
Experience:
- Lead cardiometabolic late-stage programs (incl. type 2 diabetes).
- Track record of success in academia and/or biopharma clinical R&D.
- Knowledge of global/regional regulation, ICH/GCP, adverse event management.
- Manage/train large clinical teams; experience designing/launching large teams preferred.
Key Skills/Competencies (required):
- Medical/scientific excellence; strong management and leadership in matrix environments.
- Effective influencing, conflict management, team building, accountability, and agility in uncertainty.
Non-standard/Env:
- Up to 30% travel; hybrid (on-site ~2.5 days/week). Relocation support available.
Compensation/Benefits (if hired):
- Base salary range: $214,900–$358,100 (U.S. range; Tampa, FL differs). Bonus target 22.5% of base; participation in share-based long-term incentives; 401(k) match; paid vacation/holidays; caregiver/parental and medical leave; medical/dental/vision coverage.
Application instructions: None stated in provided text.