Global Development Lead, Internal Medicine, Sr. Director (non-MD)
Pfizer
5 hours ago
Remote friendly (Pearl River, NY)
United States
Clinical Research and Development
Responsibilities:
- Lead cross-functional Clinical Development Team for assigned Internal Medicine asset(s), ensuring study design, execution, interpretation, and worldwide regulatory submission support.
- Create and gain endorsement for Clinical Development Plan and associated protocol design documents.
- Lead/partner on pediatric investigation plan/study plan, target product profile input, and regulatory activities (labels, core data sheets, Investigator Brochures, DSUR, PBRER).
- Partner with trial clinicians on governance reviews; provide therapy area/indication expertise (CRF design, signal interpretation, adverse event contextualization).
- Provide specialized medical monitoring support (if required).
- Partner on trial-level statistical analysis plan, TLFs, table-listings-figures, and database release.
- Develop submission-level deliverables (IAP, IARP, submission TLFs; SCE, SCS) and safety narrative plan; support product label development/maintenance.
- Support external stakeholder engagement (e.g., advisory boards, steering committees, DMC, adjudication committees, patients) to drive clinical strategy.
- Ensure compliance with internal SOPs and external regulatory standards; review IIR proposals.
Qualifications:
- PhD/PharmD.
- Background in chronic weight management, endocrinology, or internal medicine with Phase 1–3 clinical development and translational medicine experience.
- 8+ years relevant clinical R&D 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 skills; strong verbal/written communication; experience managing/training large clinical teams; experience designing/launching large teams preferred.
Skills/Requirements:
- Matrix leadership/influencing; conflict management; team building; accountability; effective decision-making under uncertainty.
Travel/Location:
- Up to 30% travel; hybrid role (on-site ~2.5 days/week).
Compensation/Benefits:
- Base salary $214,900–$358,100; bonus target 22.5% plus long-term incentive eligibility; comprehensive benefits (401(k), retirement contribution, paid time off, caregiver/parental leave, medical/dental/vision).
Application instructions: Not provided in the text.
- Lead cross-functional Clinical Development Team for assigned Internal Medicine asset(s), ensuring study design, execution, interpretation, and worldwide regulatory submission support.
- Create and gain endorsement for Clinical Development Plan and associated protocol design documents.
- Lead/partner on pediatric investigation plan/study plan, target product profile input, and regulatory activities (labels, core data sheets, Investigator Brochures, DSUR, PBRER).
- Partner with trial clinicians on governance reviews; provide therapy area/indication expertise (CRF design, signal interpretation, adverse event contextualization).
- Provide specialized medical monitoring support (if required).
- Partner on trial-level statistical analysis plan, TLFs, table-listings-figures, and database release.
- Develop submission-level deliverables (IAP, IARP, submission TLFs; SCE, SCS) and safety narrative plan; support product label development/maintenance.
- Support external stakeholder engagement (e.g., advisory boards, steering committees, DMC, adjudication committees, patients) to drive clinical strategy.
- Ensure compliance with internal SOPs and external regulatory standards; review IIR proposals.
Qualifications:
- PhD/PharmD.
- Background in chronic weight management, endocrinology, or internal medicine with Phase 1–3 clinical development and translational medicine experience.
- 8+ years relevant clinical R&D 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 skills; strong verbal/written communication; experience managing/training large clinical teams; experience designing/launching large teams preferred.
Skills/Requirements:
- Matrix leadership/influencing; conflict management; team building; accountability; effective decision-making under uncertainty.
Travel/Location:
- Up to 30% travel; hybrid role (on-site ~2.5 days/week).
Compensation/Benefits:
- Base salary $214,900–$358,100; bonus target 22.5% plus long-term incentive eligibility; comprehensive benefits (401(k), retirement contribution, paid time off, caregiver/parental leave, medical/dental/vision).
Application instructions: Not provided in the text.