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About the role
Key responsibilities & impact- Provide medical and scientific expertise and oversight for clinical trials
- Serve as a single point of accountability for study design, execution, monitoring, delivery, reporting, and patient safety
- Develop strategies for protocols intended to obtain worldwide approval
- Provide medical advice for risk assessment, mitigation planning, and safety issues
- Review individual-subject and cumulative safety data and monitor serious adverse events
- Participate in Safety Review Teams, Data Monitoring Committees, steering committees, and other study bodies
- Review literature and communicate safety information to study sites
- Provide medical input into clinical development plans, protocols, informed consent documents, and country feasibility
- Support study teams with monitoring guidelines, statistical analysis plans, data quality planning, and clinical review activities
- Contribute to CRO/vendor selection and ensure protocol, clinical, data-integrity, and timeline requirements are met
- Conduct medical review and interpretation of efficacy and safety data
- Collaborate on top-line reports and clinical study reports, ensuring scientific validity, quality, and timeliness
- Provide protocol-specific training to study teams, investigators, and clinical research associates
- Monitor investigator compliance with protocols and regulatory requirements
- Support issue resolution, study closeout, audit responses, and inspection readiness
- Author clinical sections of regulatory documents and contribute to abstracts, posters, presentations, and publications
- Interact with regulatory authorities, key opinion leaders, and principal investigators
- Build key opinion leader and principal investigator networks for new trials
Requirements
What you’ll need- Medical degree (M.D./D.O. or equivalent)
- 4+ years’ work experience
- Licensed by a health authority to prescribe medicines independently of supervision for at least two years after the intern/houseman year
- Used the prescribing license in a patient care setting for an aggregate duration of at least one year
- Ability to critically evaluate medical/scientific information
- Understanding of the design, development, and execution of clinical programs and studies
- Documented pharmaceutical-industry experience related to clinical research programs and registration activities
- Experience managing multiple studies
- Ability to work standard East Coast workday hours; occasional off-hours work may be required
- Ability to travel
- Authorized to be employed in the U.S. by any employer
- Permanent work authorization in the United States
- U.S. work visa sponsorship is not available now or in the future
Benefits
Comp & perks- Global Performance Plan with a bonus target of 25.0% of base salary
- Share-based long-term incentive program
- 401(k) plan with Pfizer Matching Contributions
- Additional Pfizer Retirement Savings Contribution
- Paid vacation, holiday and personal days
- Paid caregiver/parental and medical leave
- Medical, prescription drug, dental and vision coverage
- Relocation assistance may be available based on business needs and/or eligibility