Director – Vaccine Clinical Research and Development
| Company | Pfizer |
|---|---|
| Location | New City, NY, USA, Phoenixville, PA, USA |
| Salary | $226300 – $377100 |
| Type | Full-Time |
| Degrees | MD |
| Experience Level | Senior, Expert or higher |
Requirements
- Medical degree (M.D./D.O. or equivalent) with valid license for at least 2 years after graduation
- At least 2 years of experience in the pharmaceutical industry (biopharmaceutical industry or Clinical Research Organization) related to clinical research programs and registration activities, preferably for vaccines
- An investigator with significant experience in vaccine clinical studies in academic, NGO or public health institutions may be considered
- Possesses the ability to critically evaluate medical/scientific information; propose new concepts and innovative ideas in drug development
- Understands the design, development, and execution of clinical programs and studies
Responsibilities
- Provide medical and scientific expertise and oversight for Clinical Trials
- Accountable for design, execution, monitoring, delivery and reporting of one or more clinical studies
- Provide medical input during development and updates to the clinical development plan
- Ensure that documents (protocol, Informed Consent Document [ICD], etc.) meet regulatory requirements and company policy
- Provide study team with medical advice for all medical issues during risk assessment and mitigation planning
- Ensure development of and adherence to the Safety Review Plan (SRP)
- Monitor study safety issues and provide input to serious adverse events (SAEs) reports
- Participate in the Safety Review Team to evaluate medical benefits/risks
- Conduct medical review and interpretation of efficacy and safety data from clinical trials
- Provide protocol specific training to study team, investigators, clinical research associate, and others
- Interact with regulatory authorities, key opinion leaders, and principal investigators
Preferred Qualifications
- Training in Infectious Disease, Internal Medicine or Pediatrics preferred