Global Development Lead, Internal Medicine, Sr. Director (MD)
Pfizer
15 days ago
Remote friendly (New York, NY)
United States
Clinical Research and Development
Responsibilities:
- Serve as single clinical point of accountability for clinical development of assigned Internal Medicine/obesity asset(s).
- Lead cross-functional Clinical Development Team (clinical, clinical pharmacology, statistics, safety, commercial, patient access, operations) for study design, execution, and interpretation supporting global regulatory submissions.
- Create and gain endorsement for Clinical Development Plan and associated protocol design documents; ensure pediatric investigation plan/study plan development.
- Provide therapy area/indication expertise (e.g., CRF design, signal interpretation, adverse event contextualization).
- Partner with trial clinicians on governance reviews; contribute clinical strategy inputs.
- Lead/enhance trial-level statistical analysis plan, TLFs/table-listings-figures, and database release inputs.
- Develop submission-level deliverables (IAP, IARP, submission TLFs; SCE, SCS), safety narrative plan, and support product label development/maintenance.
- Support regulatory submissions and disclosures (DSUR, PBRER), product defense; ensure SOP and regulatory compliance.
- Engage external stakeholders (ad boards, steering committees, DMC, adjudication committees, patients/advocates) to inform development strategy and PDD.
Basic Qualifications:
- MD or DO.
- 8+ years clinical R&D experience; Phase 1–3 development and translational medicine experience.
- Knowledge of global/regional regulation, ICH/GCP, adverse event management.
Additional requirements/skills:
- Clinical/medical and project management capability; strong verbal/written communication.
- Experience managing/training large clinical teams; designing/launching large teams preferred.
Benefits (as stated):
- Annual base salary $274,500–$457,500; bonus target 25%; eligible for long-term incentive.
- 401(k) with matching and additional retirement contribution; paid vacation/holidays/personal days; caregiver/parental and medical leave; medical/dental/vision coverage.
Other:
- Up to 30% travel; hybrid (on-site ~2.5 days/week).
- Serve as single clinical point of accountability for clinical development of assigned Internal Medicine/obesity asset(s).
- Lead cross-functional Clinical Development Team (clinical, clinical pharmacology, statistics, safety, commercial, patient access, operations) for study design, execution, and interpretation supporting global regulatory submissions.
- Create and gain endorsement for Clinical Development Plan and associated protocol design documents; ensure pediatric investigation plan/study plan development.
- Provide therapy area/indication expertise (e.g., CRF design, signal interpretation, adverse event contextualization).
- Partner with trial clinicians on governance reviews; contribute clinical strategy inputs.
- Lead/enhance trial-level statistical analysis plan, TLFs/table-listings-figures, and database release inputs.
- Develop submission-level deliverables (IAP, IARP, submission TLFs; SCE, SCS), safety narrative plan, and support product label development/maintenance.
- Support regulatory submissions and disclosures (DSUR, PBRER), product defense; ensure SOP and regulatory compliance.
- Engage external stakeholders (ad boards, steering committees, DMC, adjudication committees, patients/advocates) to inform development strategy and PDD.
Basic Qualifications:
- MD or DO.
- 8+ years clinical R&D experience; Phase 1–3 development and translational medicine experience.
- Knowledge of global/regional regulation, ICH/GCP, adverse event management.
Additional requirements/skills:
- Clinical/medical and project management capability; strong verbal/written communication.
- Experience managing/training large clinical teams; designing/launching large teams preferred.
Benefits (as stated):
- Annual base salary $274,500–$457,500; bonus target 25%; eligible for long-term incentive.
- 401(k) with matching and additional retirement contribution; paid vacation/holidays/personal days; caregiver/parental and medical leave; medical/dental/vision coverage.
Other:
- Up to 30% travel; hybrid (on-site ~2.5 days/week).