Global Development Lead, Internal Medicine, Sr. Director (MD)
Pfizer
15 days ago
Remote friendly (Pearl River, NY)
United States
Clinical Research and Development
Responsibilities:
- Lead cross-functional clinical development for assigned asset(s) as single clinical point of accountability; design, execute, and interpret studies supporting worldwide regulatory submissions.
- Create and gain endorsement for the Clinical Development Plan and associated protocol design documents; partner across the study lifecycle.
- Contribute to trial design/execution/reporting for other late-stage assets in the Obesity portfolio.
- Negotiate clinical program tradeoffs, milestones, and ensure delivery within timelines and budget.
- Develop comprehensive global clinical development plan (incl. China and Japan) and pediatric investigation/study plans and protocol design documents.
- Provide input for target product profiles and regulatory activities (product labels, core data sheets, Investigator Brochures, DSUR, PBRER, Development Safety Update Reports, Periodic Benefit-Risk Evaluation Reports).
- Partner in governance reviews (Sci/Ops), provide therapy area/indication expertise (CRF design, signal interpretation, adverse event contextualization), and provide specialized medical monitoring support if required.
- Lead/partner in statistical deliverables (trial-level SAP, TLFs, listings/figures, database release).
- Develop submission deliverables (IAP, IARP, submission TLFs) including SCE and SCS; review/approve safety narrative plan; support product label development/maintenance.
- Engage external stakeholders (ad boards, steering committees, DMC, adjudication committees, patients/advocates) and support product defense.
- Ensure compliance with internal SOPs and external regulatory standards; review IIR proposals.
Qualifications:
- MD or DO.
- Background in chronic weight management, endocrinology, or internal medicine; experience in Phase 1–3 clinical development and translational medicine.
- 8+ years relevant clinical research and development experience (academia and/or biopharma).
- Extensive knowledge of clinical development, global/regional regulation, ICH/GCP, adverse event management.
- Demonstrated clinical/medical, administrative, and project management capabilities; strong verbal/written communication.
- Experience managing/training large teams; demonstrated experience designing/launching large teams preferred.
Skills/Competencies:
- Clinical/scientific credibility; ability to coordinate and execute clinical development lifecycle strategy.
- Management and leadership in a matrixed environment; influence cross-functional teams.
- Conflict management, team building, accountability, and ability to drive through uncertainty.
Benefits/Application:
- Up to 30% travel; hybrid role (on-site ~2.5 days/week).
- Annual base salary range: $274,500–$457,500; bonus target 25% of base; eligibility for share-based long-term incentive and comprehensive benefits.
- Application: Not specified beyond job posting.
- Lead cross-functional clinical development for assigned asset(s) as single clinical point of accountability; design, execute, and interpret studies supporting worldwide regulatory submissions.
- Create and gain endorsement for the Clinical Development Plan and associated protocol design documents; partner across the study lifecycle.
- Contribute to trial design/execution/reporting for other late-stage assets in the Obesity portfolio.
- Negotiate clinical program tradeoffs, milestones, and ensure delivery within timelines and budget.
- Develop comprehensive global clinical development plan (incl. China and Japan) and pediatric investigation/study plans and protocol design documents.
- Provide input for target product profiles and regulatory activities (product labels, core data sheets, Investigator Brochures, DSUR, PBRER, Development Safety Update Reports, Periodic Benefit-Risk Evaluation Reports).
- Partner in governance reviews (Sci/Ops), provide therapy area/indication expertise (CRF design, signal interpretation, adverse event contextualization), and provide specialized medical monitoring support if required.
- Lead/partner in statistical deliverables (trial-level SAP, TLFs, listings/figures, database release).
- Develop submission deliverables (IAP, IARP, submission TLFs) including SCE and SCS; review/approve safety narrative plan; support product label development/maintenance.
- Engage external stakeholders (ad boards, steering committees, DMC, adjudication committees, patients/advocates) and support product defense.
- Ensure compliance with internal SOPs and external regulatory standards; review IIR proposals.
Qualifications:
- MD or DO.
- Background in chronic weight management, endocrinology, or internal medicine; experience in Phase 1–3 clinical development and translational medicine.
- 8+ years relevant clinical research and development experience (academia and/or biopharma).
- Extensive knowledge of clinical development, global/regional regulation, ICH/GCP, adverse event management.
- Demonstrated clinical/medical, administrative, and project management capabilities; strong verbal/written communication.
- Experience managing/training large teams; demonstrated experience designing/launching large teams preferred.
Skills/Competencies:
- Clinical/scientific credibility; ability to coordinate and execute clinical development lifecycle strategy.
- Management and leadership in a matrixed environment; influence cross-functional teams.
- Conflict management, team building, accountability, and ability to drive through uncertainty.
Benefits/Application:
- Up to 30% travel; hybrid role (on-site ~2.5 days/week).
- Annual base salary range: $274,500–$457,500; bonus target 25% of base; eligibility for share-based long-term incentive and comprehensive benefits.
- Application: Not specified beyond job posting.