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About the Role

Serve as a Clinician within a Pfizer vaccine development program, potentially acting as a clinical lead for studies. This role involves medical monitoring, supporting regulatory interactions, and leading study teams for clinical deliverables, ensuring patient safety and providing medical expertise.

Responsibilities

• Accountable for safety across the study.
• Provide study team with medical advice for all medical issues during risk assessment and mitigation planning.
• Ensure development of and adherence to the Safety Surveillance Review Plan (SSRP).
• Perform and document regular review of individual subject safety data and cumulative safety data.
• Monitor study safety issues and provide input to serious adverse events (SAEs) reports.
• Participate in the Safety Review Team to evaluate medical benefits/risks.
• Review literature as needed to respond to safety questions.
• Communicate safety information to sites and provide responses to safety questions.
• Contribute medical input during protocol development and clinical development plan updates.
• Work closely with other medical monitors to ensure documents meet regulatory requirements and company policy.
• Provide medical input into country feasibility.
• Provide clinical input to protocol/study team for monitoring guidelines, statistics analysis plans, ICDs, clinical review forms, data edit checks, and data quality planning.
• Contribute to contract research organization/vendor selection.
• Ensure high quality of data, including appropriate patient population and adequacy of clinical assessments.
• Contribute to medical review and interpretation of efficacy and safety data.
• Provide protocol-specific training to study team, investigators, and clinical research associates.
• Interact with healthcare professionals at sites during study conduct.
• Interact with DMCs and steering committees as required.
• Notify appropriate study team personnel of the need to inform investigators of any changes in research activity and any significant new adverse events.
• Monitor investigator compliance with protocol and regulatory requirements.
• Support study team in issues resolution, study closeout, audit responses, and inspection readiness.
• Author clinical sections of regulatory documents.
• Co-author abstracts, posters, presentations, and publications.
• Contribute to budget execution of protocols.
• Support Clinical Regulatory Authority interactions by providing responses.
• Liaise with Key Opinion Leaders and Principal Investigators to build a network for new trials.

Requirements

• Medical degree (M.D./D.O. or equivalent).
• Licensed by a health authority to prescribe medicines (independent of supervision) for at least one year (post "intern/houseman" year).
• Utilized the license to prescribe medicines in a patient care setting for an aggregate duration of at least two years.
• Possesses the ability to critically evaluate medical/scientific information.
• Excellent written and oral communication.
• Understands the design, development, and execution of clinical programs and studies.
• Capacity to adapt to a fast pace and changing environment.
• Documented work experience/knowledge of statistics.
• Training and experience in infectious diseases and/or infection control in the hospital setting is preferred.
• Experience with investigational clinical trials is preferred.
• No pharmaceutical industry experience required.
• Demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
• Candidates must be authorized to be employed in the U.S. by any employer.
• U.S. work visa sponsorship is not available for this role now or in the future.
• This position requires permanent work authorization in the United States.

Skills

• Medical monitoring
• Regulatory interaction
• Study team leadership
• Patient safety
• Medical expertise
• Scientific expertise
• Protocol design
• Clinical development
• Risk assessment
• Mitigation planning
• Safety surveillance
• Serious adverse event (SAE) reporting
• Medical benefits/risks evaluation
• Literature review
• Communication
• Data integrity
• Efficacy data interpretation
• Safety data interpretation
• Training
• Investigator interaction
• Data Monitoring Committee (DMC) interaction
• Steering committee interaction
• Audit response
• Inspection readiness
• Regulatory document authoring
• Publication co-authoring
• Budget execution
• Regulatory authority interaction
• Key Opinion Leader (KOL) liaison
• Principal Investigator (PI) liaison

Location

• Hybrid

Work Type

• Hybrid
• Full-time

Experience Level

• 0-4 years

Education Level

• Medical degree (M.D./D.O. or equivalent)

Salary/Compensations

• $189,200.00 - $315,400.00
• Bonus target of 22.5% of the base salary
• Eligibility to participate in share-based long-term incentive program

Benefits

• 401(k) plan with Pfizer Matching Contributions
• Additional Pfizer Retirement Savings Contribution
• Paid vacation, holiday, and personal days
• Paid caregiver/parental and medical leave
• Health benefits (medical, prescription drug, dental, and vision coverage)
• Relocation assistance may be available

About the Company

• Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.
• Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.
• Pfizer is an E-Verify employer.

Equal Opportunity

• Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.
• Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.
• Pfizer is an E-Verify employer.