Global Development Lead, Internal Medicine, Sr. Director (MD)
Pfizer
16 days ago
Remote friendly (La Jolla, CA)
United States
Clinical Research and Development
Responsibilities:
- Lead clinical development for assigned Internal Medicine assets as single clinical point of accountability; design, execute, and interpret studies for global regulatory submissions.
- Create and gain endorsement for Clinical Development Plan and protocol design documents; partner across clinical, clinical pharmacology, statistics, safety, commercial, patient access, and operations.
- Drive pediatric investigation plan/study plan and ensure trial feasibility and optimized execution.
- Provide therapy area/indication expertise (e.g., CRF design, signal interpretation, adverse event contextualization) and specialized medical monitoring as needed.
- Partner on trial statistical analysis deliverables (SAP; TLFs; table-listings-figures; database release).
- Develop submission deliverables (IAP, IARP, submission TLFs) including SCE and SCS; review/approve submission-level safety narrative; support label development/maintenance.
- Support regulatory submissions and disclosures (DSUR, PBRER) and product defense; ensure compliance with SOPs and regulatory standards.
- Engage external stakeholders (Ad boards, Steering Committees, DMC, adjudication committees, patients).
- Support Obesity portfolio leadership opportunities; may review IIR proposals.
Basic Qualifications:
- MD or DO.
Experience/Skills:
- Chronic weight management/endocrinology/internal medicine background; Phase 1–3 and translational medicine experience.
- 8+ years clinical research/clinical development experience (academia and/or biopharma).
- Knowledge of global/regional regulation, ICH/GCP, adverse event management.
- Strong clinical/medical, administrative, and project management; excellent written/verbal communication.
- Demonstrated leadership in managing/training large clinical teams.
Non-standard/Work Location:
- Up to 30% travel; hybrid role (on-site ~2.5 days/week).
Compensation/Benefits (as stated):
- Base salary: $274,500–$457,500; bonus target 25%; 401(k) with matching; additional retirement contribution; paid leave; medical/dental/vision.
- Lead clinical development for assigned Internal Medicine assets as single clinical point of accountability; design, execute, and interpret studies for global regulatory submissions.
- Create and gain endorsement for Clinical Development Plan and protocol design documents; partner across clinical, clinical pharmacology, statistics, safety, commercial, patient access, and operations.
- Drive pediatric investigation plan/study plan and ensure trial feasibility and optimized execution.
- Provide therapy area/indication expertise (e.g., CRF design, signal interpretation, adverse event contextualization) and specialized medical monitoring as needed.
- Partner on trial statistical analysis deliverables (SAP; TLFs; table-listings-figures; database release).
- Develop submission deliverables (IAP, IARP, submission TLFs) including SCE and SCS; review/approve submission-level safety narrative; support label development/maintenance.
- Support regulatory submissions and disclosures (DSUR, PBRER) and product defense; ensure compliance with SOPs and regulatory standards.
- Engage external stakeholders (Ad boards, Steering Committees, DMC, adjudication committees, patients).
- Support Obesity portfolio leadership opportunities; may review IIR proposals.
Basic Qualifications:
- MD or DO.
Experience/Skills:
- Chronic weight management/endocrinology/internal medicine background; Phase 1–3 and translational medicine experience.
- 8+ years clinical research/clinical development experience (academia and/or biopharma).
- Knowledge of global/regional regulation, ICH/GCP, adverse event management.
- Strong clinical/medical, administrative, and project management; excellent written/verbal communication.
- Demonstrated leadership in managing/training large clinical teams.
Non-standard/Work Location:
- Up to 30% travel; hybrid role (on-site ~2.5 days/week).
Compensation/Benefits (as stated):
- Base salary: $274,500–$457,500; bonus target 25%; 401(k) with matching; additional retirement contribution; paid leave; medical/dental/vision.