Global Development Lead, Internal Medicine, Sr. Director (non-MD)
Pfizer
14 hours ago
Remote friendly (Cambridge, MA)
United States
Clinical Research and Development
Responsibilities:
- Lead clinical development for assigned asset(s), including design, execution, and interpretation of studies supporting worldwide regulatory submissions.
- Own and gain endorsement for the Clinical Development Plan and associated protocol design documents.
- Lead cross-functional Clinical Development Team (clinical, clinical pharmacology, statistics, safety, commercial, patient access, operations).
- Develop global clinical development plan for approval and reimbursement (including China and Japan) and create pediatric investigation/study plan and protocol design docs.
- Provide therapy area/indication expertise for clinical data review (CRF design, signal interpretation support, adverse event contextualization).
- Contribute to trial-level statistical analysis plan, TLFs, and database release; partner with statistics/programming.
- Develop submission-level deliverables (IAP, IARP, submission TLFs) including SCE and SCS; review/approve submission safety narrative plans.
- Support regulatory submissions and disclosure/product defense (DSUR, PBRER).
- Support target product profile input; support product label development and maintenance.
- Engage external stakeholders (ad boards, steering committees, DMC, adjudication committees, patients/patient advocates) to generate strategic insights.
- Ensure compliance with internal SOPs and external regulatory standards.
Basic Qualifications:
- PhD/PharmD.
- 8+ years relevant experience with success in academia and/or biopharma clinical research and development.
- Background in chronic weight management, endocrinology, or internal medicine; Phase 1–3 clinical development and translational medicine experience.
- Extensive knowledge of clinical development, global/regional regulation, ICH/GCP, and adverse event management.
- Demonstrated clinical/medical, administrative, and project management capability; strong written and verbal communication.
- Demonstrated experience managing/training large clinical development teams; designing/launching large teams preferred.
Skills/Competencies (required):
- Clinical/scientific credibility; ability to coordinate/execute clinical development lifecycle strategy.
- Cross-functional matrix leadership and influence; leadership and staff persuasion.
- Conflict management, team building, accountability, and ability to drive results amid change.
Work/Environment:
- Up to 30% travel.
- Hybrid: live within commuting distance; average 2.5 days/week on-site.
Benefits/Compensation:
- Base salary range: $214,900.00–$358,100.00; bonus target 22.5% of base; eligible for share-based long-term incentive; comprehensive benefits (e.g., 401(k) with match, retirement contribution, vacation/holidays, caregiver/parental leave, and medical/dental/vision).
- Lead clinical development for assigned asset(s), including design, execution, and interpretation of studies supporting worldwide regulatory submissions.
- Own and gain endorsement for the Clinical Development Plan and associated protocol design documents.
- Lead cross-functional Clinical Development Team (clinical, clinical pharmacology, statistics, safety, commercial, patient access, operations).
- Develop global clinical development plan for approval and reimbursement (including China and Japan) and create pediatric investigation/study plan and protocol design docs.
- Provide therapy area/indication expertise for clinical data review (CRF design, signal interpretation support, adverse event contextualization).
- Contribute to trial-level statistical analysis plan, TLFs, and database release; partner with statistics/programming.
- Develop submission-level deliverables (IAP, IARP, submission TLFs) including SCE and SCS; review/approve submission safety narrative plans.
- Support regulatory submissions and disclosure/product defense (DSUR, PBRER).
- Support target product profile input; support product label development and maintenance.
- Engage external stakeholders (ad boards, steering committees, DMC, adjudication committees, patients/patient advocates) to generate strategic insights.
- Ensure compliance with internal SOPs and external regulatory standards.
Basic Qualifications:
- PhD/PharmD.
- 8+ years relevant experience with success in academia and/or biopharma clinical research and development.
- Background in chronic weight management, endocrinology, or internal medicine; Phase 1–3 clinical development and translational medicine experience.
- Extensive knowledge of clinical development, global/regional regulation, ICH/GCP, and adverse event management.
- Demonstrated clinical/medical, administrative, and project management capability; strong written and verbal communication.
- Demonstrated experience managing/training large clinical development teams; designing/launching large teams preferred.
Skills/Competencies (required):
- Clinical/scientific credibility; ability to coordinate/execute clinical development lifecycle strategy.
- Cross-functional matrix leadership and influence; leadership and staff persuasion.
- Conflict management, team building, accountability, and ability to drive results amid change.
Work/Environment:
- Up to 30% travel.
- Hybrid: live within commuting distance; average 2.5 days/week on-site.
Benefits/Compensation:
- Base salary range: $214,900.00–$358,100.00; bonus target 22.5% of base; eligible for share-based long-term incentive; comprehensive benefits (e.g., 401(k) with match, retirement contribution, vacation/holidays, caregiver/parental leave, and medical/dental/vision).