Global Development Lead, Internal Medicine, Sr. Director (non-MD)
Pfizer
15 days ago
Remote friendly (Bothell, WA)
United States
Clinical Research and Development
Responsibilities:
- Lead clinical development for assigned Internal Medicine asset(s) as the single clinical point of accountability.
- 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.
- Create and gain endorsement for the Clinical Development Plan and associated protocol design documents; partner across the study lifecycle.
- For obesity portfolio, support additional clinical leadership opportunities (trial design, execution, reporting for late-stage assets).
- Provide product/program input to target product profile(s); develop clinical development enabling strategies (digital/innovation, patient engagement).
- Partner with trial clinicians on governance reviews; provide therapy area/indication expertise (CRF design, signal interpretation, AE contextualization).
- Provide specialized medical monitoring support when required.
- Contribute to trial-level statistical analysis plans, TLFs/table listings-figures, and database release with statistics/programming.
- Develop submission-level deliverables (IAP, IARP, submission TLFs) including SCE and SCS; support safety narrative plan review/approval.
- Support product label development and maintenance.
- Engage external stakeholders (e.g., ad boards, steering committees, DMC, adjudication committees, patients/patient advocates) to inform clinical strategy and PDD development.
- Provide regulatory submission support (DSUR, PBRER) and product defense; ensure compliance with SOPs and regulatory standards.
Basic Qualifications / Requirements:
- PhD or PharmD.
- 8+ years relevant experience in clinical research/development (academia and/or biopharma).
- 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; strong verbal/written communication.
- Experience managing and training large clinical development teams (designing/launching large teams preferred).
Skills/Competencies:
- Medical/scientific credibility and ability to coordinate clinical development/lifecycle strategy; comfortable with scientific/mechanistic and commercial/regulatory issues.
- Leadership and influence in matrix environments; able to manage/motivate internal teams.
- Strong conflict management, team building, accountability, and ability to perform amid uncertainty.
Travel/Environment:
- Up to 30% travel.
- Hybrid role: live within commuting distance; work on-site ~2.5 days/week.
Application instructions:
- Not provided in the text.
- Lead clinical development for assigned Internal Medicine asset(s) as the single clinical point of accountability.
- 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.
- Create and gain endorsement for the Clinical Development Plan and associated protocol design documents; partner across the study lifecycle.
- For obesity portfolio, support additional clinical leadership opportunities (trial design, execution, reporting for late-stage assets).
- Provide product/program input to target product profile(s); develop clinical development enabling strategies (digital/innovation, patient engagement).
- Partner with trial clinicians on governance reviews; provide therapy area/indication expertise (CRF design, signal interpretation, AE contextualization).
- Provide specialized medical monitoring support when required.
- Contribute to trial-level statistical analysis plans, TLFs/table listings-figures, and database release with statistics/programming.
- Develop submission-level deliverables (IAP, IARP, submission TLFs) including SCE and SCS; support safety narrative plan review/approval.
- Support product label development and maintenance.
- Engage external stakeholders (e.g., ad boards, steering committees, DMC, adjudication committees, patients/patient advocates) to inform clinical strategy and PDD development.
- Provide regulatory submission support (DSUR, PBRER) and product defense; ensure compliance with SOPs and regulatory standards.
Basic Qualifications / Requirements:
- PhD or PharmD.
- 8+ years relevant experience in clinical research/development (academia and/or biopharma).
- 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; strong verbal/written communication.
- Experience managing and training large clinical development teams (designing/launching large teams preferred).
Skills/Competencies:
- Medical/scientific credibility and ability to coordinate clinical development/lifecycle strategy; comfortable with scientific/mechanistic and commercial/regulatory issues.
- Leadership and influence in matrix environments; able to manage/motivate internal teams.
- Strong conflict management, team building, accountability, and ability to perform amid uncertainty.
Travel/Environment:
- Up to 30% travel.
- Hybrid role: live within commuting distance; work on-site ~2.5 days/week.
Application instructions:
- Not provided in the text.