Global Development Lead (MD ED)
Pfizer
4 hours ago
Remote friendly (New York, NY)
United States
Clinical Research and Development
Responsibilities:
- Lead cross-functional Clinical Development Team (clinical, clinical pharmacology, statistics, safety, commercial, patient access, operations) to design, execute, and interpret studies supporting worldwide regulatory submissions.
- Manage multiple assets across lifecycle stages and balance competing priorities.
- Create and gain endorsement for Clinical Development Plan and associated protocol design documents.
- Provide input for target product profile(s) and regulatory activities (product labels, core data sheets, Investigator Brochures, DSURs, Periodic Benefit-Risk Evaluation Reports).
- Lead clinical governance reviews with trial clinicians (incl. SRC) and provide category strategy and insights.
- Provide therapy area/indication expertise for clinical data review (CRF design, signal interpretation, adverse event contextualization).
- Provide specialized medical monitoring support (if required).
- Partner on trial-level statistical analysis plan and trial deliverables (table-listings-figures, database release with statistics/programming).
- Develop submission deliverables (IAP, IARP, submission TLFs) and submission-level deliverables including SCE and SCS.
- Support interpretation/communication of clinical trial data; review/approve submission-level safety narrative plan.
- Support product label development and maintenance.
- Engage external stakeholders (ad boards, steering committees, DMC, adjudication committees, patients/patient advocates) to inform clinical development strategy and PDD development.
- Provide regulatory submission support (DSUR, PBRER) and product defense; ensure compliance with internal SOPs and external regulatory standards.
- Review IIR proposals.
Qualifications:
- Required: MD or DO; minimum 5+ years MD/DO experience.
Preferred Qualifications/Skills:
- 15+ years relevant experience with track record in academia and/or biopharma clinical research and development.
- Clinical drug development experience across all development phases; experience with NDA submissions and large complex global development programs.
- Specialist experience in neurology, psychiatry, pediatrics, or internal medicine.
- Extensive knowledge of clinical development, global/regional regulation, ICH/GCP, and adverse event management.
- Strong clinical/medical, administrative, and project management skills; effective verbal and written communication.
- Demonstrated experience managing and training large clinical development teams.
Benefits:
- Relocation support available.
- Eligible for Pfizer Global Performance Plan bonus (30% of base salary target) and share-based long-term incentive program.
- 401(k) with Pfizer matching contributions and additional retirement contribution; paid vacation/holidays/personal days; paid caregiver/parental and medical leave; medical, prescription drug, dental, and vision coverage.
Application/Work conditions:
- Up to 30% travel may be required.
- Hybrid role; work on-site ~2.5 days/week within commuting distance.
- Lead cross-functional Clinical Development Team (clinical, clinical pharmacology, statistics, safety, commercial, patient access, operations) to design, execute, and interpret studies supporting worldwide regulatory submissions.
- Manage multiple assets across lifecycle stages and balance competing priorities.
- Create and gain endorsement for Clinical Development Plan and associated protocol design documents.
- Provide input for target product profile(s) and regulatory activities (product labels, core data sheets, Investigator Brochures, DSURs, Periodic Benefit-Risk Evaluation Reports).
- Lead clinical governance reviews with trial clinicians (incl. SRC) and provide category strategy and insights.
- Provide therapy area/indication expertise for clinical data review (CRF design, signal interpretation, adverse event contextualization).
- Provide specialized medical monitoring support (if required).
- Partner on trial-level statistical analysis plan and trial deliverables (table-listings-figures, database release with statistics/programming).
- Develop submission deliverables (IAP, IARP, submission TLFs) and submission-level deliverables including SCE and SCS.
- Support interpretation/communication of clinical trial data; review/approve submission-level safety narrative plan.
- Support product label development and maintenance.
- Engage external stakeholders (ad boards, steering committees, DMC, adjudication committees, patients/patient advocates) to inform clinical development strategy and PDD development.
- Provide regulatory submission support (DSUR, PBRER) and product defense; ensure compliance with internal SOPs and external regulatory standards.
- Review IIR proposals.
Qualifications:
- Required: MD or DO; minimum 5+ years MD/DO experience.
Preferred Qualifications/Skills:
- 15+ years relevant experience with track record in academia and/or biopharma clinical research and development.
- Clinical drug development experience across all development phases; experience with NDA submissions and large complex global development programs.
- Specialist experience in neurology, psychiatry, pediatrics, or internal medicine.
- Extensive knowledge of clinical development, global/regional regulation, ICH/GCP, and adverse event management.
- Strong clinical/medical, administrative, and project management skills; effective verbal and written communication.
- Demonstrated experience managing and training large clinical development teams.
Benefits:
- Relocation support available.
- Eligible for Pfizer Global Performance Plan bonus (30% of base salary target) and share-based long-term incentive program.
- 401(k) with Pfizer matching contributions and additional retirement contribution; paid vacation/holidays/personal days; paid caregiver/parental and medical leave; medical, prescription drug, dental, and vision coverage.
Application/Work conditions:
- Up to 30% travel may be required.
- Hybrid role; work on-site ~2.5 days/week within commuting distance.