Clinical Development Medical, Associate Director

Pfizer • Collegeville, PA

22h • $189,200 - $315,400 • Hybrid

About The Position

The primary purpose of this role is to serve as a clinician within a Pfizer vaccine development program. The position may serve as the clinical lead for one or more studies and works closely with the global clinical program lead, who is ultimately responsible for execution of the overall program. Within a matrix team, the role executes studies, performs medical monitoring, supports regulatory interactions, and leads study teams on clinical deliverables.

The clinician provides medical and scientific expertise and oversight for clinical trials and is a single point of accountability for the design, execution, monitoring, delivery, and reporting of one or more clinical studies, with responsibility for ensuring patient safety. The role collaborates with study and program teams, investigators, healthcare professionals, regulatory authorities, key opinion leaders, and principal investigators. Some responsibilities are performed under the supervision of a medical monitor or Director/Senior Director.

Requirements

• Medical degree (M.D., D.O., or equivalent).
• Licensed by a health authority to prescribe medicines independently of supervision for at least one year after the intern/houseman year, and has used the license to prescribe medicines in a patient care setting for an aggregate duration of at least two years.
• 0–4 years of work experience.
• Ability to critically evaluate medical and scientific information.
• Excellent written and oral communication skills.
• 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, to support problem-solving and productivity.
• Curiosity about how AI tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use.
• Must be authorized to work in the United States for any employer; U.S. work visa sponsorship is not available.
• Position requires permanent work authorization in the United States.

Nice To Haves

• Documented work experience or knowledge of statistics.
• Training and experience in infectious diseases and/or hospital infection control.
• Experience with investigational clinical trials.
• No pharmaceutical industry experience is required.
• Breadth of diverse leadership experiences and capabilities, including influencing and collaborating with peers, developing and coaching others, and guiding colleagues’ work to achieve meaningful outcomes and business impact.

Responsibilities

• Provide medical oversight and advice on study safety, including risk assessment and mitigation planning, to support quality, compliance, and patient safety.
• Ensure development of and adherence to the Safety Surveillance Review Plan; review and document individual subject safety data and review cumulative safety data with the safety risk lead, or delegate appropriate review responsibilities as specified in the plan.
• Monitor study safety issues, contribute medical context to serious adverse event reports, and communicate safety information and responses to safety questions to study sites.
• Participate in the Safety Review Team to evaluate medical benefits and risks in support of targeted clinical indications.
• Review literature as needed to address safety questions from the Safety Review Team, Data Monitoring Committee, or other study bodies.
• Contribute medical input to protocol development and updates to the clinical development plan.
• Collaborate with medical monitors on protocols, informed consent documents, and other documents to ensure regulatory and company policy requirements are met and documents are reviewed by IRBs/IECs.
• Provide medical input into country feasibility.
• Provide clinical input, with supervision, on monitoring guidelines, statistical analysis plans, informed consent documents, clinical review forms, data edit checks, and data quality planning.
• Contribute to contract research organization and vendor selection, ensuring medical and technical requirements for data integrity are applied and study conduct aligns with protocol requirements, clinical plan expectations, and timelines.
• Work with the study team to ensure high-quality data, including appropriate patient populations and clinical assessments.
• Contribute to medical review and interpretation of trial efficacy and safety data, including top-line reports with the study statistician and clinical study reports with the medical writer; be accountable for the overall quality and timeliness of analysis and reporting.
• Provide protocol-specific training to study team members, investigators, clinical research associates, and others.
• Interact with healthcare professionals at study sites to support quality, compliance, and patient safety.
• Interact with Data Monitoring Committees and steering committees as required.
• Notify appropriate study team personnel when investigators need to be informed about changes in research activity or significant new adverse events.
• Monitor investigator compliance with protocol and regulatory requirements.
• Support issue resolution, study closeout, audit responses, and inspection readiness.
• Author clinical sections of regulatory documents under supervision, including Investigator Brochures, Annual Reports, Investigational New Drug sections, and clinical study reports.
• May co-author abstracts, posters, presentations, and publications.
• May contribute to protocol budget execution.
• May support clinical regulatory authority interactions and provide responses.
• Liaise with key opinion leaders and principal investigators in countries to build networks for new trials.

Benefits

• 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution.
• Paid vacation, holidays, and personal days.
• Paid caregiver, parental, and medical leave.
• Medical, prescription drug, dental, and vision coverage.
• Eligible for participation in Pfizer’s Global Performance Plan, with a bonus target of 22.5% of base salary.
• Eligible to participate in Pfizer’s share-based long-term incentive program.
• Relocation assistance may be available based on business needs and/or eligibility.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Ph.D. or professional degree