Global Development Lead, Internal Medicine (MD, Sr. Director)
Pfizer
4 months ago
Remote friendly (Cambridge, MA)
United States
Clinical Research and Development
Responsibilities
- Lead cross-functional Clinical Development Team for assigned Internal Medicine asset(s), designing, executing, and interpreting studies to support worldwide regulatory submissions.
- Create and gain endorsement for Clinical Development Plan and protocol design documents; ensure delivery within agreed timelines and budget.
- Develop global clinical development strategy to secure approval and reimbursement (including China and Japan) and create pediatric investigation/study plans.
- Provide therapy-area expertise for clinical review (e.g., CRF design, signal interpretation, adverse event contextualization).
- Partner on governance reviews; contribute to statistical analysis plan, TLFs, table-listings-figures, and database releases.
- Develop submission deliverables (IAP, IARP, submission TLFs; SCE, SCS), including safety narrative plan review/approval.
- Support product label development/maintenance and regulatory disclosure/defense (DSUR, PBRER).
- Engage external stakeholders (e.g., advisory boards, steering committees, DMC, adjudication committees, patients/patient advocates).
Basic Qualifications
- MD or DO.
- Cardiologist with cardiovascular outcome trials or large complex global development programs.
- 8+ years clinical R&D experience (academia and/or biopharma) and extensive knowledge of global/regional regulation, ICH/GCP, and adverse event management.
Skills/Leadership
- Strong medical/scientific credibility; leadership and influence in a matrix environment; conflict management, accountability, team building.
Other
- Up to 30% travel; hybrid role (on-site ~2.5 days/week).
- Benefits (explicitly stated): 401(k) with matching, additional retirement contribution, paid vacation/holidays/personal days, caregiver/parental and medical leave, and medical/dental/vision coverage.
- Lead cross-functional Clinical Development Team for assigned Internal Medicine asset(s), designing, executing, and interpreting studies to support worldwide regulatory submissions.
- Create and gain endorsement for Clinical Development Plan and protocol design documents; ensure delivery within agreed timelines and budget.
- Develop global clinical development strategy to secure approval and reimbursement (including China and Japan) and create pediatric investigation/study plans.
- Provide therapy-area expertise for clinical review (e.g., CRF design, signal interpretation, adverse event contextualization).
- Partner on governance reviews; contribute to statistical analysis plan, TLFs, table-listings-figures, and database releases.
- Develop submission deliverables (IAP, IARP, submission TLFs; SCE, SCS), including safety narrative plan review/approval.
- Support product label development/maintenance and regulatory disclosure/defense (DSUR, PBRER).
- Engage external stakeholders (e.g., advisory boards, steering committees, DMC, adjudication committees, patients/patient advocates).
Basic Qualifications
- MD or DO.
- Cardiologist with cardiovascular outcome trials or large complex global development programs.
- 8+ years clinical R&D experience (academia and/or biopharma) and extensive knowledge of global/regional regulation, ICH/GCP, and adverse event management.
Skills/Leadership
- Strong medical/scientific credibility; leadership and influence in a matrix environment; conflict management, accountability, team building.
Other
- Up to 30% travel; hybrid role (on-site ~2.5 days/week).
- Benefits (explicitly stated): 401(k) with matching, additional retirement contribution, paid vacation/holidays/personal days, caregiver/parental and medical leave, and medical/dental/vision coverage.