Director, Vaccines Clinical Research (MD required)
Pfizer
4 hours ago
Remote friendly (Pennsylvania, United States)
United States
Clinical Research and Development
Role Summary
- Provide medical and scientific expertise/oversight for clinical trials; single point of accountability for design, execution, monitoring, delivery, and reporting of one or more studies to ensure patient safety.
- May design development strategy for multiple protocols for worldwide approval.
- May participate in standing committees, perform due diligence for in-licensing, and support business development.
Role Responsibilities
- Accountable for safety across the study: provide medical advice for risk assessment/mitigation; ensure adherence to SSRP; review individual and cumulative subject safety data; monitor safety issues and input to SAE reports; provide medical context for benefit-risk; participate in safety review team; review literature; communicate safety info to sites.
- Protocol design and strategy: provide medical input to clinical development plan updates; design studies meeting objectives; ensure protocol/ICD regulatory compliance and IRB/IEC review; provide medical input into country feasibility.
- Support study team: advise on monitoring guidelines, stats plans, ICDs, review forms, data edit checks, and data quality; support vendor selection; ensure data quality; review/interpret efficacy & safety data and deliver reports; ensure validity of study conclusions; oversee safety/efficacy disclosures; provide protocol training; ensure investigator compliance; support issue resolution, closeout, audits, and inspections.
- Support program team: author clinical sections of regulatory documents; may co-author publications/presentations.
- Interact with regulators/KOLs/PIs: support responses; liaise to build KOL/PI network.
Basic Qualifications
- M.D./D.O. (or equivalent).
- 4+ years work experience.
- Licensed to prescribe medicines independently for 2+ years post-intern/houseman and used license for at least 1 year in patient care.
- Ability to critically evaluate medical/scientific information.
- Understand design/development/execution of clinical programs/studies.
- Documented pharma industry experience in clinical research/registration activities.
- Responsible for managing multiple studies.
Preferred Qualifications
- Experience/knowledge of statistics.
- Infectious diseases/infection control training/experience.
- Experience with investigational clinical trials.
- Excellent written/oral skills; ability to adapt to fast-changing environments.
- Demonstrated leadership: influence/collaborate, coach others, guide colleagues to create business impact.
Compensation/Benefits (as stated)
- Base salary range: $239,900–$399,800; bonus target 25% of base; eligibility for share-based long-term incentive and comprehensive benefits.
Other
- Hybrid: live within commuting distance; work on-site ~2.5 days/week or more as needed.
- Travel (US and outside US) and occasional off-hours work may be required.
- Provide medical and scientific expertise/oversight for clinical trials; single point of accountability for design, execution, monitoring, delivery, and reporting of one or more studies to ensure patient safety.
- May design development strategy for multiple protocols for worldwide approval.
- May participate in standing committees, perform due diligence for in-licensing, and support business development.
Role Responsibilities
- Accountable for safety across the study: provide medical advice for risk assessment/mitigation; ensure adherence to SSRP; review individual and cumulative subject safety data; monitor safety issues and input to SAE reports; provide medical context for benefit-risk; participate in safety review team; review literature; communicate safety info to sites.
- Protocol design and strategy: provide medical input to clinical development plan updates; design studies meeting objectives; ensure protocol/ICD regulatory compliance and IRB/IEC review; provide medical input into country feasibility.
- Support study team: advise on monitoring guidelines, stats plans, ICDs, review forms, data edit checks, and data quality; support vendor selection; ensure data quality; review/interpret efficacy & safety data and deliver reports; ensure validity of study conclusions; oversee safety/efficacy disclosures; provide protocol training; ensure investigator compliance; support issue resolution, closeout, audits, and inspections.
- Support program team: author clinical sections of regulatory documents; may co-author publications/presentations.
- Interact with regulators/KOLs/PIs: support responses; liaise to build KOL/PI network.
Basic Qualifications
- M.D./D.O. (or equivalent).
- 4+ years work experience.
- Licensed to prescribe medicines independently for 2+ years post-intern/houseman and used license for at least 1 year in patient care.
- Ability to critically evaluate medical/scientific information.
- Understand design/development/execution of clinical programs/studies.
- Documented pharma industry experience in clinical research/registration activities.
- Responsible for managing multiple studies.
Preferred Qualifications
- Experience/knowledge of statistics.
- Infectious diseases/infection control training/experience.
- Experience with investigational clinical trials.
- Excellent written/oral skills; ability to adapt to fast-changing environments.
- Demonstrated leadership: influence/collaborate, coach others, guide colleagues to create business impact.
Compensation/Benefits (as stated)
- Base salary range: $239,900–$399,800; bonus target 25% of base; eligibility for share-based long-term incentive and comprehensive benefits.
Other
- Hybrid: live within commuting distance; work on-site ~2.5 days/week or more as needed.
- Travel (US and outside US) and occasional off-hours work may be required.