Global Development Lead, Internal Medicine (MD, Sr. Director)
Pfizer
4 months ago
Remote friendly (Bothell, WA)
United States
Clinical Research and Development
Responsibilities:
- Lead the 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.
- Secure global approval and reimbursement (including China and Japan) via comprehensive clinical development planning; develop pediatric investigation/study plan and associated protocol design docs.
- Provide product/program input for target product profiles (TPPs) and support regulatory activities (product labels, core data sheets, Investigator Brochures, DSUR, Periodic Benefit-Risk Evaluation Reports).
- Drive innovative thinking and bold decision-making across clinical development programs.
- Develop clinical development enabling strategies (digital/innovation and patient engagement approaches).
- Partner with trial clinicians on governance reviews and provide category clinical development strategy input.
- Provide therapy area/indication expertise for clinical data review (including CRF design, signal interpretation, and 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; responsible for SCE and SCS).
- Support interpretation and 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 support clinical development strategy and PDD development.
- Provide regulatory submission support (DSUR, PBRER disclosure deliverables and product defense) and ensure compliance with internal SOPs and external regulatory standards.
- Review IIR proposals.
Qualifications:
- MD or DO
- Cardiologist with cardiovascular outcome trials or large complex, global development programs.
- 8+ years relevant experience in clinical research and development (academia and/or biopharmaceutical industry) with a track record of success.
- Extensive knowledge of clinical development, global/regional regulation, ICH/GCP, and adverse event management.
- Demonstrated clinical/medical, administrative, and project management capabilities; effective verbal and written communication.
- Demonstrated experience managing and training large clinical development teams; designing and launching large teams preferred.
Competency requirements (core):
- Medical/scientific credibility; ability to coordinate/execute clinical development or lifecycle strategy.
- Management and leadership in a complex matrix environment; influence cross-functional teams.
- Strong influencing, conflict management, team building, accountability, and ability to operate amid uncertainty.
Non-standard requirements:
- Up to 30% travel may be required.
- Hybrid: live within commuting distance; work on-site ~2.5 days/week.
- Lead the 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.
- Secure global approval and reimbursement (including China and Japan) via comprehensive clinical development planning; develop pediatric investigation/study plan and associated protocol design docs.
- Provide product/program input for target product profiles (TPPs) and support regulatory activities (product labels, core data sheets, Investigator Brochures, DSUR, Periodic Benefit-Risk Evaluation Reports).
- Drive innovative thinking and bold decision-making across clinical development programs.
- Develop clinical development enabling strategies (digital/innovation and patient engagement approaches).
- Partner with trial clinicians on governance reviews and provide category clinical development strategy input.
- Provide therapy area/indication expertise for clinical data review (including CRF design, signal interpretation, and 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; responsible for SCE and SCS).
- Support interpretation and 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 support clinical development strategy and PDD development.
- Provide regulatory submission support (DSUR, PBRER disclosure deliverables and product defense) and ensure compliance with internal SOPs and external regulatory standards.
- Review IIR proposals.
Qualifications:
- MD or DO
- Cardiologist with cardiovascular outcome trials or large complex, global development programs.
- 8+ years relevant experience in clinical research and development (academia and/or biopharmaceutical industry) with a track record of success.
- Extensive knowledge of clinical development, global/regional regulation, ICH/GCP, and adverse event management.
- Demonstrated clinical/medical, administrative, and project management capabilities; effective verbal and written communication.
- Demonstrated experience managing and training large clinical development teams; designing and launching large teams preferred.
Competency requirements (core):
- Medical/scientific credibility; ability to coordinate/execute clinical development or lifecycle strategy.
- Management and leadership in a complex matrix environment; influence cross-functional teams.
- Strong influencing, conflict management, team building, accountability, and ability to operate amid uncertainty.
Non-standard requirements:
- Up to 30% travel may be required.
- Hybrid: live within commuting distance; work on-site ~2.5 days/week.