Global Development Lead, Internal Medicine, Sr. Director (MD)
Pfizer
9 hours ago
Remote friendly (Cambridge, MA)
United States
Clinical Research and Development
Responsibilities
- Lead cross-functional clinical development for assigned Internal Medicine asset(s), accountable for study design, execution, and interpretation for global regulatory submissions.
- Create and secure endorsement of the Clinical Development Plan and protocol design documents; support lifecycle governance with trial clinicians.
- Negotiate clinical program tradeoffs, milestones, timelines, and budget; ensure feasibility and optimized operations.
- Provide therapeutic area/indication expertise (e.g., CRF design, signal interpretation, adverse event contextualization).
- Contribute to statistical planning (SAP, TLFs, database release) and submission deliverables (IAP/IARP, submission TLFs; SCE/SCS; IAP/IARP).
- Support regulatory submissions and product defense; contribute to DSUR/PBRER and safety narrative plans.
- Support label development/maintenance; engage key external stakeholders (ad boards, steering committees, DMC, adjudication committees, patients).
- Develop clinical development enabling strategies (including digital/innovation and patient engagement); may support additional Obesity portfolio assets.
Qualifications
- MD or DO.
- Background in chronic weight management, endocrinology, or internal medicine; Phase 1–3 clinical development and translational medicine experience.
- 8+ years clinical R&D experience (academia and/or biopharma).
- Extensive knowledge of clinical development, global/regional regulation, ICH/GCP, and adverse event management.
- Demonstrated leadership, project management, and experience managing/training large teams.
Benefits / Work
- Hybrid role (on-site ~2.5 days/week); up to 30% travel.
- Eligible for Global Performance Plan bonus (25% target) and long-term incentive; comprehensive benefits including 401(k) matching, vacation/holidays, caregiver/parental and medical leave, and medical/dental/vision.
- Lead cross-functional clinical development for assigned Internal Medicine asset(s), accountable for study design, execution, and interpretation for global regulatory submissions.
- Create and secure endorsement of the Clinical Development Plan and protocol design documents; support lifecycle governance with trial clinicians.
- Negotiate clinical program tradeoffs, milestones, timelines, and budget; ensure feasibility and optimized operations.
- Provide therapeutic area/indication expertise (e.g., CRF design, signal interpretation, adverse event contextualization).
- Contribute to statistical planning (SAP, TLFs, database release) and submission deliverables (IAP/IARP, submission TLFs; SCE/SCS; IAP/IARP).
- Support regulatory submissions and product defense; contribute to DSUR/PBRER and safety narrative plans.
- Support label development/maintenance; engage key external stakeholders (ad boards, steering committees, DMC, adjudication committees, patients).
- Develop clinical development enabling strategies (including digital/innovation and patient engagement); may support additional Obesity portfolio assets.
Qualifications
- MD or DO.
- Background in chronic weight management, endocrinology, or internal medicine; Phase 1–3 clinical development and translational medicine experience.
- 8+ years clinical R&D experience (academia and/or biopharma).
- Extensive knowledge of clinical development, global/regional regulation, ICH/GCP, and adverse event management.
- Demonstrated leadership, project management, and experience managing/training large teams.
Benefits / Work
- Hybrid role (on-site ~2.5 days/week); up to 30% travel.
- Eligible for Global Performance Plan bonus (25% target) and long-term incentive; comprehensive benefits including 401(k) matching, vacation/holidays, caregiver/parental and medical leave, and medical/dental/vision.