Global Development Lead, Internal Medicine, Sr. Director (non-MD)
Pfizer
14 hours ago
Remote friendly (Pennsylvania, United States)
United States
Clinical Research and Development
Responsibilities:
- Serve as single clinical point of accountability for assigned internal medicine asset(s); lead cross-functional clinical development teams (clinical, clinical pharmacology, stats, safety, commercial, patient access, operations) to design, execute, and interpret studies for global regulatory submissions.
- Create and gain endorsement for the Clinical Development Plan and associated protocol design documents; partner across the study lifecycle.
- Lead pediatric investigation plan/study plan and protocol design with trial clinicians to ensure feasibility and optimized execution.
- Provide therapy area/indication expertise for CRF design, signal interpretation, and contextualization of adverse events.
- Support trial-level statistical analysis plan, TLFs, database release, and submission deliverables (IAP, IARP, submission TLFs; SCE, SCS, clinical overview).
- Support safety narrative plan review/approval; product label development/maintenance.
- Provide regulatory submission support (DSUR, PBRER) and product defense; ensure compliance with internal SOPs and external regulatory standards.
- Engage key external stakeholders (ad boards, steering committees, DMC, adjudication committees, patients/advocates).
Basic Qualifications:
- PhD or PharmD.
- 8+ years relevant experience; Phase 1–3 clinical development and translational medicine; expertise in clinical development, global/regional regulation, ICH/GCP, and adverse event management.
- Background in chronic weight management, endocrinology, or internal medicine preferred.
- Demonstrated clinical, administrative, and project management; communication; managing/training large teams.
Competency Requirements (summary):
- Matrix leadership/influence, conflict management/mentoring, team building, accountability, and ability to work amid change.
Benefits (explicitly stated):
- Bonus target 22.5% of base salary; 401(k) with matching, additional retirement contribution, paid vacation/holidays/personal days, caregiver/parental leave, medical/dental/vision.
Other:
- Up to 30% travel; hybrid work (on-site ~2.5 days/week).
- Relocation support may be available.
- Serve as single clinical point of accountability for assigned internal medicine asset(s); lead cross-functional clinical development teams (clinical, clinical pharmacology, stats, safety, commercial, patient access, operations) to design, execute, and interpret studies for global regulatory submissions.
- Create and gain endorsement for the Clinical Development Plan and associated protocol design documents; partner across the study lifecycle.
- Lead pediatric investigation plan/study plan and protocol design with trial clinicians to ensure feasibility and optimized execution.
- Provide therapy area/indication expertise for CRF design, signal interpretation, and contextualization of adverse events.
- Support trial-level statistical analysis plan, TLFs, database release, and submission deliverables (IAP, IARP, submission TLFs; SCE, SCS, clinical overview).
- Support safety narrative plan review/approval; product label development/maintenance.
- Provide regulatory submission support (DSUR, PBRER) and product defense; ensure compliance with internal SOPs and external regulatory standards.
- Engage key external stakeholders (ad boards, steering committees, DMC, adjudication committees, patients/advocates).
Basic Qualifications:
- PhD or PharmD.
- 8+ years relevant experience; Phase 1–3 clinical development and translational medicine; expertise in clinical development, global/regional regulation, ICH/GCP, and adverse event management.
- Background in chronic weight management, endocrinology, or internal medicine preferred.
- Demonstrated clinical, administrative, and project management; communication; managing/training large teams.
Competency Requirements (summary):
- Matrix leadership/influence, conflict management/mentoring, team building, accountability, and ability to work amid change.
Benefits (explicitly stated):
- Bonus target 22.5% of base salary; 401(k) with matching, additional retirement contribution, paid vacation/holidays/personal days, caregiver/parental leave, medical/dental/vision.
Other:
- Up to 30% travel; hybrid work (on-site ~2.5 days/week).
- Relocation support may be available.