Global Development Lead, Internal Medicine (MD, Sr. Director)
Pfizer
4 months ago
Remote friendly (New York, NY)
United States
$217,800 - $444,100 USD yearly
Clinical Research and Development
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.
- Create and gain endorsement for the Clinical Development Plan and associated protocol design documents.
- Develop comprehensive clinical development plan to secure global approval and reimbursement (including China and Japan), including pediatric investigation/study plan and protocol design.
- Provide input for target product profile(s) and regulatory activities (product labels, core data sheets, Investigator Brochures, Development Safety Update Reports, Periodic Benefit-Risk Evaluation Reports).
- Drive innovative decision-making and develop clinical development enabling strategies (digital/innovation and patient engagement).
- Partner with trial clinicians on governance reviews (incl. Sci/Ops) and provide category strategy and indication/therapy area expertise (CRF design, signal interpretation, adverse event contextualization).
- Contribute to trial-level statistical analysis plan, table-listings-figures, and database release (with statistics/programming).
- Develop submission deliverables (IAP, IARP, submission TLFs) including SCE and SCS; support interpretation/communication of trial data and review/approve submission-level safety narrative plan.
- Support product label development/maintenance.
- Engage external stakeholders (e.g., advisory boards, steering committees, DMC, adjudication committees, patients/patient advocates) to support clinical development strategy and PDD development.
- Provide regulatory submission support (DSUR, PBRER) including disclosure and product defense; ensure compliance with internal SOPs and external regulatory standards; review IIR proposals.
Qualifications:
- MD or DO.
Experience (Required):
- Cardiologist with cardiovascular outcome trials or large complex global development programs.
- 8+ years of relevant experience in clinical research and development (academia and/or biopharmaceutical industry).
- Extensive knowledge of clinical development, global/regional regulation, ICH/GCP, and adverse event management.
- Demonstrated clinical/medical, administrative, and project management capabilities; strong verbal and written communication.
- Demonstrated experience managing and training large clinical development teams (designing/launching large teams preferred).
Skills/Competencies (Required/Key):
- Medical/scientific credibility; ability to coordinate and execute clinical development/lifecycle strategy; comfort discussing scientific/mechanistic, commercial, and regulatory issues.
- Management and leadership in a complex matrix environment; ability to influence cross-functional teams.
- Strong influencing, conflict management, team-building, accountability, and change agility.
Travel/Environment:
- Up to 30% travel may be required.
- Hybrid role; live within commuting distance and work on-site ~2.5 days/week.
Benefits/Compensation (if explicitly stated):
- Annual base salary range: $274,500.00–$444,100.00; bonus target 25% of base salary; participation in global performance plan; eligibility for share-based long-term incentive.
- Benefits include 401(k) with Pfizer matching contributions (and additional retirement contribution), paid vacation/holidays/personal days, paid caregiver/parental and medical leave, and medical/prescription drug/dental/vision coverage.
- Relocation support available.
Application instructions:
- Not provided in the supplied text.
- 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.
- Create and gain endorsement for the Clinical Development Plan and associated protocol design documents.
- Develop comprehensive clinical development plan to secure global approval and reimbursement (including China and Japan), including pediatric investigation/study plan and protocol design.
- Provide input for target product profile(s) and regulatory activities (product labels, core data sheets, Investigator Brochures, Development Safety Update Reports, Periodic Benefit-Risk Evaluation Reports).
- Drive innovative decision-making and develop clinical development enabling strategies (digital/innovation and patient engagement).
- Partner with trial clinicians on governance reviews (incl. Sci/Ops) and provide category strategy and indication/therapy area expertise (CRF design, signal interpretation, adverse event contextualization).
- Contribute to trial-level statistical analysis plan, table-listings-figures, and database release (with statistics/programming).
- Develop submission deliverables (IAP, IARP, submission TLFs) including SCE and SCS; support interpretation/communication of trial data and review/approve submission-level safety narrative plan.
- Support product label development/maintenance.
- Engage external stakeholders (e.g., advisory boards, steering committees, DMC, adjudication committees, patients/patient advocates) to support clinical development strategy and PDD development.
- Provide regulatory submission support (DSUR, PBRER) including disclosure and product defense; ensure compliance with internal SOPs and external regulatory standards; review IIR proposals.
Qualifications:
- MD or DO.
Experience (Required):
- Cardiologist with cardiovascular outcome trials or large complex global development programs.
- 8+ years of relevant experience in clinical research and development (academia and/or biopharmaceutical industry).
- Extensive knowledge of clinical development, global/regional regulation, ICH/GCP, and adverse event management.
- Demonstrated clinical/medical, administrative, and project management capabilities; strong verbal and written communication.
- Demonstrated experience managing and training large clinical development teams (designing/launching large teams preferred).
Skills/Competencies (Required/Key):
- Medical/scientific credibility; ability to coordinate and execute clinical development/lifecycle strategy; comfort discussing scientific/mechanistic, commercial, and regulatory issues.
- Management and leadership in a complex matrix environment; ability to influence cross-functional teams.
- Strong influencing, conflict management, team-building, accountability, and change agility.
Travel/Environment:
- Up to 30% travel may be required.
- Hybrid role; live within commuting distance and work on-site ~2.5 days/week.
Benefits/Compensation (if explicitly stated):
- Annual base salary range: $274,500.00–$444,100.00; bonus target 25% of base salary; participation in global performance plan; eligibility for share-based long-term incentive.
- Benefits include 401(k) with Pfizer matching contributions (and additional retirement contribution), paid vacation/holidays/personal days, paid caregiver/parental and medical leave, and medical/prescription drug/dental/vision coverage.
- Relocation support available.
Application instructions:
- Not provided in the supplied text.