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About the role
Key responsibilities & impact- Provide medical and scientific expertise and oversight for one or more clinical trials
- Serve as the single point of accountability for study design, execution, monitoring, delivery, reporting, and patient safety
- Develop strategies for protocols intended to obtain worldwide compound approvals
- Oversee study safety, including safety surveillance plans, individual and cumulative safety data review, SAE reporting, and benefit-risk assessments
- 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, protocol design, country feasibility, and study strategy
- Ensure protocols, informed consent documents, and related documents meet regulatory and company requirements
- Provide clinical input on monitoring guidelines, statistical analysis plans, clinical review forms, data edit checks, and data quality planning
- Contribute to CRO/vendor selection and ensure medical and technical data-integrity requirements are applied
- Review and interpret clinical trial efficacy and safety data
- Deliver top-line reports and clinical study reports in collaboration with statisticians and medical writers
- Ensure medical and scientific validity of study reports and conclusions
- Disclose appropriate safety and efficacy data through ClinicalTrials.gov, EudraCT, or Pfizer.com
- Provide protocol-specific training to study teams, investigators, clinical research associates, and others
- Interact with healthcare professionals, regulatory authorities, key opinion leaders, and principal investigators
- Monitor investigator compliance with protocol and regulatory requirements
- Support issue resolution, study closeout, audit responses, and inspection readiness
- Author clinical sections of regulatory documents, including Investigator Brochures, Annual Reports, IND sections, and clinical study reports
- May co-author abstracts, posters, presentations, and publications
- May contribute to protocol budget execution
- Liaise with key opinion leaders and principal investigators to build 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, with occasional off-hours work
- Ability to travel
- Candidates must be authorized to be employed in the U.S. by any employer
- Permanent work authorization in the United States required
- U.S. work visa sponsorship is not available now or in the future
- Preferred: documented work experience/knowledge of statistics
- Preferred: training and experience in infectious diseases and/or hospital infection control
- Preferred: experience with investigational clinical trials
- Excellent written and oral skills
- Ability to adapt to a fast-paced and changing environment
- Leadership capabilities including influencing and collaborating with peers, developing and coaching others, and overseeing colleagues’ work
Benefits
Comp & perks- 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
- Global Performance Plan bonus target of 25.0% of base salary
- Share-based long-term incentive program
- Relocation assistance may be available based on business needs and/or eligibility
