Clinical Development Medical Director
Pfizer
12 hours ago
Remote friendly (Pennsylvania, United States)
United States
Clinical Research and Development
Responsibilities
- Serve as a clinician within a vaccine development program; may act as clinical lead for one or more studies, providing medical and scientific expertise and oversight to ensure patient safety.
- Provide medical advice for medical issues during risk assessment/mitigation; ensure adherence to the Safety Surveillance Review Plan (SSRP) including review of individual and cumulative safety data.
- Monitor safety issues; provide input to SAE reports with appropriate medical context; review literature for safety questions.
- Communicate safety information to sites; participate in safety review activities to evaluate medical benefits/risks.
- Provide medical input for protocol and clinical development plan updates; ensure protocol/ICD meet regulatory and IRB/IEC requirements; provide input into country feasibility.
- Support study execution: provide clinical input to monitoring guidelines, SAPs, ICDs, review forms, data edit checks, and data quality planning; support vendor/ CRO selection; ensure data quality.
- Contribute to efficacy/safety review and reporting (top-line and clinical study report), deliver protocol-specific training, interact with sites, DMCs, and steering committees; support issue resolution, closeout, audits, and inspections.
- Support regulatory authority interactions; liaise with KOLs and Principal Investigators; author clinical sections of regulatory documents; participate in standing committees and in-licensing/due diligence activities.
Basic Qualifications
- MD/DO (or equivalent) with valid license for at least 2 years post-graduation.
- 4+ years work experience.
- Licensed to prescribe independently for at least 2 years (post intern/houseman) and used license in patient care for at least 1 year.
- Proven pharma/biopharma or CRO experience in clinical research programs/registration activities (preferably vaccines) OR significant vaccine clinical study investigator experience in academic/NGO/public health institutions.
Preferred Qualifications
- Training in Infectious Disease, Internal Medicine, or Pediatrics.
- Documented statistics knowledge/work experience; infectious diseases and/or infection control experience; experience with investigational clinical trials.
Skills/Capabilities
- Leadership experience; ability to influence/collaborate; coach others; critically evaluate medical/scientific information; excellent written and oral communication; understands clinical program/study design and execution; adapts to fast-paced change.
Work Location & Compensation (explicit)
- Hybrid (some office presence required).
- Base salary: $239,900.00–$399,800.00; bonus target 25% of base salary; eligible for share-based long-term incentive; comprehensive benefits (401(k) match, retirement contribution, paid leave, medical/dental/vision).
- Serve as a clinician within a vaccine development program; may act as clinical lead for one or more studies, providing medical and scientific expertise and oversight to ensure patient safety.
- Provide medical advice for medical issues during risk assessment/mitigation; ensure adherence to the Safety Surveillance Review Plan (SSRP) including review of individual and cumulative safety data.
- Monitor safety issues; provide input to SAE reports with appropriate medical context; review literature for safety questions.
- Communicate safety information to sites; participate in safety review activities to evaluate medical benefits/risks.
- Provide medical input for protocol and clinical development plan updates; ensure protocol/ICD meet regulatory and IRB/IEC requirements; provide input into country feasibility.
- Support study execution: provide clinical input to monitoring guidelines, SAPs, ICDs, review forms, data edit checks, and data quality planning; support vendor/ CRO selection; ensure data quality.
- Contribute to efficacy/safety review and reporting (top-line and clinical study report), deliver protocol-specific training, interact with sites, DMCs, and steering committees; support issue resolution, closeout, audits, and inspections.
- Support regulatory authority interactions; liaise with KOLs and Principal Investigators; author clinical sections of regulatory documents; participate in standing committees and in-licensing/due diligence activities.
Basic Qualifications
- MD/DO (or equivalent) with valid license for at least 2 years post-graduation.
- 4+ years work experience.
- Licensed to prescribe independently for at least 2 years (post intern/houseman) and used license in patient care for at least 1 year.
- Proven pharma/biopharma or CRO experience in clinical research programs/registration activities (preferably vaccines) OR significant vaccine clinical study investigator experience in academic/NGO/public health institutions.
Preferred Qualifications
- Training in Infectious Disease, Internal Medicine, or Pediatrics.
- Documented statistics knowledge/work experience; infectious diseases and/or infection control experience; experience with investigational clinical trials.
Skills/Capabilities
- Leadership experience; ability to influence/collaborate; coach others; critically evaluate medical/scientific information; excellent written and oral communication; understands clinical program/study design and execution; adapts to fast-paced change.
Work Location & Compensation (explicit)
- Hybrid (some office presence required).
- Base salary: $239,900.00–$399,800.00; bonus target 25% of base salary; eligible for share-based long-term incentive; comprehensive benefits (401(k) match, retirement contribution, paid leave, medical/dental/vision).