Global Development Lead, Internal Medicine, Sr. Director (non-MD)
Pfizer
15 days ago
Remote friendly (New York, NY)
United States
Clinical Research and Development
Responsibilities:
- Lead clinical development for assigned asset(s) as single clinical point of accountability; design, execute, and interpret studies supporting worldwide regulatory submissions.
- Create and gain endorsement for Clinical Development Plan and associated protocol design documents.
- Lead cross-functional Clinical Development Team (clinical, clinical pharmacology, statistics, safety, commercial, patient access, operations) and partner with trial clinicians across study lifecycle.
- Drive pediatric investigation plan/study plan and protocol design; ensure global approval and reimbursement (including China and Japan).
- Provide therapy area/indication expertise for clinical data review (CRF design, signal interpretation, adverse event contextualization).
- Contribute to trial-level statistical analysis plan, TLFs, table-listings-figures, and database release (with statistics/programming).
- Develop submission deliverables (IAP, IARP, submission TLFs) including SCE and SCS; review/approve submission-level safety narrative plan.
- Support regulatory submissions and defense; contribute to DSUR and PBRER disclosure deliverables.
- Support target product profiles; contribute to product labels, core data sheets, Investigator Brochures, Development Safety Update Reports, and Periodic Benefit-Risk Evaluation Reports.
- Engage external stakeholders (e.g., advisory boards, steering committees, DMC, adjudication committees, patients/patient advocates) to generate insights for clinical development and PDD.
- Ensure compliance with internal SOPs and external regulatory standards.
- Review IIR proposals; provide specialized monitoring support if required.
Basic Qualifications:
- PhD/PharmD.
- 8+ years relevant experience in clinical research and development (academia and/or biopharma), with Phase 1–3 and translational medicine experience.
- Background in chronic weight management, endocrinology, or internal medicine.
- Extensive knowledge of clinical development, global/regional regulation, ICH/GCP, and adverse event management.
Skills/Competencies (required):
- Strong clinical/medical, administrative, and project management; verbal/written communication.
- Ability to manage and train large, cross-functional teams; matrix leadership and influence.
- Conflict management, team building, accountability, and ability to operate amid uncertainty/change.
Preferred:
- Demonstrated experience designing and launching large teams.
Travel/Work Location:
- Up to 30% travel; hybrid role with on-site work ~2.5 days/week.
Benefits:
- Eligible for Global Performance Plan bonus (22.5% target) and share-based long-term incentive; 401(k) match and additional retirement contribution; paid vacation/holidays/personal days; paid caregiver/parental and medical leave; medical/prescription/dental/vision.
Application instructions:
- Authorization to be employed in the U.S. required; U.S. work visa sponsorship not available.
- Lead clinical development for assigned asset(s) as single clinical point of accountability; design, execute, and interpret studies supporting worldwide regulatory submissions.
- Create and gain endorsement for Clinical Development Plan and associated protocol design documents.
- Lead cross-functional Clinical Development Team (clinical, clinical pharmacology, statistics, safety, commercial, patient access, operations) and partner with trial clinicians across study lifecycle.
- Drive pediatric investigation plan/study plan and protocol design; ensure global approval and reimbursement (including China and Japan).
- Provide therapy area/indication expertise for clinical data review (CRF design, signal interpretation, adverse event contextualization).
- Contribute to trial-level statistical analysis plan, TLFs, table-listings-figures, and database release (with statistics/programming).
- Develop submission deliverables (IAP, IARP, submission TLFs) including SCE and SCS; review/approve submission-level safety narrative plan.
- Support regulatory submissions and defense; contribute to DSUR and PBRER disclosure deliverables.
- Support target product profiles; contribute to product labels, core data sheets, Investigator Brochures, Development Safety Update Reports, and Periodic Benefit-Risk Evaluation Reports.
- Engage external stakeholders (e.g., advisory boards, steering committees, DMC, adjudication committees, patients/patient advocates) to generate insights for clinical development and PDD.
- Ensure compliance with internal SOPs and external regulatory standards.
- Review IIR proposals; provide specialized monitoring support if required.
Basic Qualifications:
- PhD/PharmD.
- 8+ years relevant experience in clinical research and development (academia and/or biopharma), with Phase 1–3 and translational medicine experience.
- Background in chronic weight management, endocrinology, or internal medicine.
- Extensive knowledge of clinical development, global/regional regulation, ICH/GCP, and adverse event management.
Skills/Competencies (required):
- Strong clinical/medical, administrative, and project management; verbal/written communication.
- Ability to manage and train large, cross-functional teams; matrix leadership and influence.
- Conflict management, team building, accountability, and ability to operate amid uncertainty/change.
Preferred:
- Demonstrated experience designing and launching large teams.
Travel/Work Location:
- Up to 30% travel; hybrid role with on-site work ~2.5 days/week.
Benefits:
- Eligible for Global Performance Plan bonus (22.5% target) and share-based long-term incentive; 401(k) match and additional retirement contribution; paid vacation/holidays/personal days; paid caregiver/parental and medical leave; medical/prescription/dental/vision.
Application instructions:
- Authorization to be employed in the U.S. required; U.S. work visa sponsorship not available.