We are looking for a collaborative and innovative team member to join Pfizer’s Global Medical Epidemiology (GME) and contribute to our mission of understanding diseases across all stages of drug development, which accelerates the availability of breakthrough medicines that impact patients’ lives. The Epidemiology Scientist – Contractor, (potential for contract-to-hire), position provides an opportunity for an epidemiologist to play an essential role in advancing the generation of real-world evidence and its application to drug development. This role requires someone with strong technical expertise, analytic ability, creativity and communication skills.
The Epidemiology Scientist–Contractor will also partner with internal and external stakeholders on the design and conduct of epidemiologic research to inform clinical development programs and to support regulatory submissions to the FDA, EMA and other agencies globally. The role will involve internal and external collaborations in conceptualizing and proposing epidemiologic studies, and in writing and reviewing protocols, reports, and presentations. Studies will be communicated in writing and in presentations to internal stakeholders, regulatory authorities, medical professionals and others. The incumbent will also develop and adopt innovative pharmacoepidemiologic methodologies and contribute thought leadership internally and externally regarding Pfizer’s understanding of disease epidemiology/ pharmacoepidemiology to support decision-making across portfolios.
Specifically, the contractor will likely support the Internal medicine, rare disease and emerging markets therapeutic area epidemiology activities. GME colleagues are located in New York and Collegeville, PA, but Pfizer is flexible regarding remote work for the right candidate and full remote work is an option.
Propose and produce GME deliverables for development and product/asset teams, including:
• Background safety and effectiveness epidemiology studies and disease natural history studies.
• Indicated population cohorts for external control arms and regulatory submission.
• Post-approval effectiveness studies
• Feasibility assessments and identification of fit-for-purpose data for observational research
• Other epidemiology studies (e.g., special subpopulations, new indications)
• Critical assessment and review of epidemiological data and literature
• Design and implement primary or secondary data collection or hybrid design pharmacoepidemiologic studies intended to quantify benefits and/or risks potentially associated with Pfizer products
• Participate in GME peer review of study protocols and reports
• Support multiple product teams on epidemiology related issues
• Work collaboratively with key stakeholders internally (such as Clinical, Medical, Regulatory, Outcomes Research, and Data Scientists) and externally (such as academics, regulators, vendors)
• Provide support of and/or attend FDA Advisory Committee meetings and EMA Oral Explanations and other related interactions and negotiations with regulatory agencies on epidemiologic issues as needed
About the Company:
Pfizer’s Global Medical Epidemiology (GME) group conducts research, often using large, external data bases, to generate a better understanding of disease context and medical outcomes and improve medical decision-making. The three pillars of GME’s remit are: (i) Regulatory Use of Epidemiology Data, (ii) Disease Natural History Studies to inform Clinical Trial Design, and (iii) Epidemiology Data for Quantitative Benefit-Risk Assessment. GME’s impacts include improving the efficiency and likelihood of success of early phase clinical trials, building more robust benefit-risk profiles to provide a more thorough assessment of new products, and incorporating these insights to support regulatory filings. GME’s value is based on deeper understanding of disease that improves quality and precision of Pfizer medical decisions. The mission of GME is to employ the scientific methods and principles of epidemiology to secure regulatory approval, accelerate clinical development, and build benefit-risk profiles.