Global Development Lead (non-MD ED)
Pfizer
5 hours ago
Remote friendly (Pennsylvania, United States)
United States
Clinical Research and Development
Job Responsibilities:
- Lead cross-functional Clinical Development Team (clinical, clinical pharmacology, statistics, safety, commercial, patient access, operations) for design, execution, and interpretation of studies supporting worldwide regulatory submissions.
- Own Clinical Development Plan and associated protocol design documents; serve as clinical point of accountability for assigned asset(s).
- Lead global clinical program delivery (timeline/budget), including pediatric investigation plan/study plan and protocol feasibility/optimized operations.
- Provide product/program input to target product profile(s); develop clinical development enabling strategies (e.g., digital/innovation, patient engagement).
- Partner on governance reviews (including SRC), CRF design, signal interpretation, and adverse event contextualization.
- Collaborate on trial-level statistical analysis plans, TLFs/table-listings-figures, and database release.
- Develop submission deliverables (IAP, IARP, submission TLFs) including SCE and SCS; support safety narrative plan approval.
- Support product label development/maintenance; engage external stakeholders (ad boards, steering committees, DMC, adjudication committees, patients/patient advocates).
- Provide regulatory submission support (DSUR, PBRER) and product defense; ensure compliance with SOPs and regulatory standards; review IIR proposals.
Qualifications:
- Required: PharmD, PhD, DVM, or MS
- Minimum experience (Non-MD): PharmD 5+ years; PhD 7+ years; DVM 5+ years; MS 10+ years
Preferred Qualifications/Skills:
- 15+ years clinical R&D experience (academia and/or biopharma); experience across all phases and NDA submissions; large global programs.
- Knowledge of global/regional regulation, ICH/GCP, adverse event management.
- Strong project/administrative management and verbal/written communication; experience managing/training large teams.
- Leadership, influencing, conflict management, team building, accountability, and agility in uncertainty.
Benefits:
- Up to 30% travel; hybrid work; relocation support available. (Base salary/bonus/benefits described in posting.)
- Lead cross-functional Clinical Development Team (clinical, clinical pharmacology, statistics, safety, commercial, patient access, operations) for design, execution, and interpretation of studies supporting worldwide regulatory submissions.
- Own Clinical Development Plan and associated protocol design documents; serve as clinical point of accountability for assigned asset(s).
- Lead global clinical program delivery (timeline/budget), including pediatric investigation plan/study plan and protocol feasibility/optimized operations.
- Provide product/program input to target product profile(s); develop clinical development enabling strategies (e.g., digital/innovation, patient engagement).
- Partner on governance reviews (including SRC), CRF design, signal interpretation, and adverse event contextualization.
- Collaborate on trial-level statistical analysis plans, TLFs/table-listings-figures, and database release.
- Develop submission deliverables (IAP, IARP, submission TLFs) including SCE and SCS; support safety narrative plan approval.
- Support product label development/maintenance; engage external stakeholders (ad boards, steering committees, DMC, adjudication committees, patients/patient advocates).
- Provide regulatory submission support (DSUR, PBRER) and product defense; ensure compliance with SOPs and regulatory standards; review IIR proposals.
Qualifications:
- Required: PharmD, PhD, DVM, or MS
- Minimum experience (Non-MD): PharmD 5+ years; PhD 7+ years; DVM 5+ years; MS 10+ years
Preferred Qualifications/Skills:
- 15+ years clinical R&D experience (academia and/or biopharma); experience across all phases and NDA submissions; large global programs.
- Knowledge of global/regional regulation, ICH/GCP, adverse event management.
- Strong project/administrative management and verbal/written communication; experience managing/training large teams.
- Leadership, influencing, conflict management, team building, accountability, and agility in uncertainty.
Benefits:
- Up to 30% travel; hybrid work; relocation support available. (Base salary/bonus/benefits described in posting.)