Description
The primary purpose of this role is to serve as a Clinician within a Pfizer vaccine development program.
You will work closely with the global clinical program lead and serve as a clinical lead for one or more studies within a clinical program.
Your responsibilities will include:
Accountable for safety across the study
- Providing medical advice for all medical issues during risk assessment and mitigation planning
- Ensuring development of and adherence to the Safety Surveillance Review Plan (SSRP)
- Monitoring study safety issues and providing input to serious adverse events (SAEs) reports
- Participating in the Safety Review Team to evaluate medical benefits/risks
- Reviewing literature as needed to respond to safety questions
- Communicating safety information to sites across the study
Protocol design and strategy
- Contributing towards medical input during protocol development and updates to the clinical development plan
- Working closely with other medical monitors to ensure documents meet regulatory requirements and company policy
- Providing medical input into country feasibility
Support study team
- Providing clinical input to protocol/study team for monitoring guidelines, statistics analysis plans, and data quality planning
- Contributing to contract research organization/vendor selection
- Working with study team to ensure high-quality data
- Contributing to medical review and interpretation of efficacy and safety data
- Providing protocol-specific training to study team, investigators, and clinical research associates
- Interacting with healthcare professionals at sites during the conduct of the study
Supports the program team
- Authoring clinical sections of regulatory documents
- Co-authoring abstracts, posters, presentations, and publications
- Contributing to budget execution of protocols
Interact with regulatory authorities, key opinion leaders, and principal investigators
- Supporting Clinical Regulatory Authority interactions
- Liaising with Key Opinion Leaders and Principal Investigators in countries
Basic qualifications:
- Medical degree (M.D./D.O. or equivalent)
- Licensed by a health authority to prescribe medicines (independent of supervision) for at least one year
- 0-4 years' work experience
- Ability to critically evaluate medical/scientific information
- Excellent written and oral communication
- Understanding of the design, development, and execution of clinical programs and studies
- Capacity to adapt to a fast-paced and changing environment
- Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot
- Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices
Preferred qualifications:
- Documented work experience/knowledge of statistics
- Training and experience in infectious diseases and/or infection control in the hospital setting
- Experience with investigational clinical trials
Additional details:
- Hybrid role requiring you to live within commuting distance and work on-site an average of 2.5 days per week
- Annual base salary ranging from $189,200.00 to $315,400.00
- Eligible for participation in Pfizer's Global Performance Plan and share-based long-term incentive program
- Comprehensive benefits package, including 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits