Global Development Lead, Internal Medicine, Sr. Director (MD)
Pfizer
16 days ago
Remote friendly (Pennsylvania, United States)
United States
Clinical Research and Development
Responsibilities:
- Lead cross-functional clinical development teams for assigned Internal Medicine/portfolio assets; design, execute, and interpret studies supporting worldwide regulatory submissions.
- Create and gain endorsement for the Clinical Development Plan and associated protocol design documents.
- Negotiate clinical program tradeoffs and milestones; ensure delivery in line with timelines and budget.
- Develop comprehensive global clinical development plans (including China/Japan) and pediatric investigation plan/study plan with trial clinicians to ensure feasibility and optimized execution.
- Provide product/program input for target product profiles; develop clinical development enabling strategies (digital/innovation and patient engagement).
- Partner with trial clinicians on governance reviews; provide therapy area/indication expertise for clinical data review (CRF design, signal interpretation, adverse event contextualization).
- Support trial-level statistical analysis planning, TLF/Table/List/Figure development, and database releases with statistics/programming.
- Develop submission deliverables (IAP, IARP, submission TLFs) including SCE and SCS; review/approve submission-level safety narrative plan.
- Support product label development/maintenance.
- Provide regulatory submission support (DSUR, PBRER) including disclosure deliverables and product defense.
- Engage external stakeholders (e.g., advisory boards, steering committees, DMC, adjudication committees, patients/advocates).
- 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 with Phase 1–3 clinical development and translational medicine experience.
- 8+ years relevant clinical research and development experience (academia and/or biopharma).
- Extensive knowledge of clinical development, global/regional regulation, ICH/GCP, and adverse event management.
- Demonstrated clinical/medical, administrative, and project management; strong written/verbal communication.
- Demonstrated experience managing/training large clinical development teams; experience designing/launching large teams preferred.
Skills/Leadership:
- Ability to influence cross-functional matrix teams; persuasive effective staff leader.
- Strong influencing, conflict management, team building, accountability, and ability to drive in uncertainty.
Benefits:
- Annual base salary range: $274,500–$457,500; bonus target 25% of base; participation in long-term incentive plan.
- 401(k) with Pfizer matching; retirement savings contribution; paid vacation/holidays/personal days; paid caregiver/parental and medical leave; medical/dental/vision coverage.
Application/Logistics:
- Up to 30% travel; hybrid role (on-site ~2.5 days/week).
- Relocation support may be available (based on business needs/eligibility).
- Lead cross-functional clinical development teams for assigned Internal Medicine/portfolio assets; design, execute, and interpret studies supporting worldwide regulatory submissions.
- Create and gain endorsement for the Clinical Development Plan and associated protocol design documents.
- Negotiate clinical program tradeoffs and milestones; ensure delivery in line with timelines and budget.
- Develop comprehensive global clinical development plans (including China/Japan) and pediatric investigation plan/study plan with trial clinicians to ensure feasibility and optimized execution.
- Provide product/program input for target product profiles; develop clinical development enabling strategies (digital/innovation and patient engagement).
- Partner with trial clinicians on governance reviews; provide therapy area/indication expertise for clinical data review (CRF design, signal interpretation, adverse event contextualization).
- Support trial-level statistical analysis planning, TLF/Table/List/Figure development, and database releases with statistics/programming.
- Develop submission deliverables (IAP, IARP, submission TLFs) including SCE and SCS; review/approve submission-level safety narrative plan.
- Support product label development/maintenance.
- Provide regulatory submission support (DSUR, PBRER) including disclosure deliverables and product defense.
- Engage external stakeholders (e.g., advisory boards, steering committees, DMC, adjudication committees, patients/advocates).
- 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 with Phase 1–3 clinical development and translational medicine experience.
- 8+ years relevant clinical research and development experience (academia and/or biopharma).
- Extensive knowledge of clinical development, global/regional regulation, ICH/GCP, and adverse event management.
- Demonstrated clinical/medical, administrative, and project management; strong written/verbal communication.
- Demonstrated experience managing/training large clinical development teams; experience designing/launching large teams preferred.
Skills/Leadership:
- Ability to influence cross-functional matrix teams; persuasive effective staff leader.
- Strong influencing, conflict management, team building, accountability, and ability to drive in uncertainty.
Benefits:
- Annual base salary range: $274,500–$457,500; bonus target 25% of base; participation in long-term incentive plan.
- 401(k) with Pfizer matching; retirement savings contribution; paid vacation/holidays/personal days; paid caregiver/parental and medical leave; medical/dental/vision coverage.
Application/Logistics:
- Up to 30% travel; hybrid role (on-site ~2.5 days/week).
- Relocation support may be available (based on business needs/eligibility).