Pfizer Director, Epidemiology Scientist in New York City, New York
The Global Medical Epidemiology (GME) & Big Data Analysis (BDA) Shared Services group is an internal, client-facing advisory service function in Pfizer's WMS/WRDM organization. The group works closely with Pfizer's research units, business units, medical affairs group, and other functional areas to thoroughly understand regulatory/business priorities and address epidemiology research opportunities and challenges for internal and external stakeholders.
The Epidemiology Scientist will partner with internal and external stakeholders on the design and conduct of epidemiologic research for regulatory submissions to the FDA, EMA and other agencies globally. The role will involve collaborations with GME & BDA colleagues in the writing and reviewing protocols, epidemiological study reports and presentation of scientific findings to regulatory authorities, medical professionals and others. Also, the Epidemiology Scientist will work with external partners in the development/adoption of epidemiological research methodologies and the generation of use cases for regulatory application of risk and effectiveness characterization. The Epidemiology Scientist will contribute thought leadership internally and externally regarding Pfizer's understanding of disease epidemiology/ pharmacoepidemiology to support epidemiological benefit-risk assessments across portfolios.
This role requires someone with strong strategic thinking, technical expertise, leadership, and communication skills.
The Epidemiology Scientist will report directly to the Epidemiology Strategist Oncology and Vaccines Lead , Global Medical Epidemiology and Big Data Analysis, based in New York.
Propose and carry out various components of GME & BDA deliverables for development and product/asset teams, including:
Epidemiology background literature sections and supplemental analyses for the Risk Management Plan (RMP), Paediatric Investigation Plans (PIPs), and Orphan Drug Destination
Epidemiology sections for other regulatory documents (e.g., ad-hoc regulatory queries, briefing documents)
Background epidemiology studies, natural progression of disease studies and user characterization studies
Indicated population cohorts for external control arms and regulatory requests
Alternative pathway identification
Post-approval effectiveness studies and their feasibility assessments
Other epidemiology studies (e.g., special subpopulations, new indications)
Provide critical assessment of epidemiological data and literature
Design and implement multiple database, de novo , or hybrid design pharmacoepidemiologic studies intended to quantify benefits and/or risks potentially associated with Pfizer products
Present and publish results of epidemiological studies at scientific conferences and peer-reviewed journals
Support multiple product teams on epidemiology related issues
Work collaboratively with key stakeholders internally (such as Clinical, Medical, Regulatory) 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
EDUCATION & COMMUNICATION
Contribute to the continuing education of relevant line functions on the use of pharmacoepidemiology methods and study designs
Develop and implement strategic communication plans to educate Pfizer stakeholders of the value, opportunities, data, methods, analytics, and processes to implement alternative pathways and studies
Influence the external environment as a public spokesperson and demonstrated leader (e.g., leadership and membership in PhRMA, ISPE or other scientific bodies, scientific presentations and publications)
Publication and presentation of pharmacoepidemiology projects at internal meetings, and external industry conference/workshops
Develop effective relationships with external thought leaders in pharmacoepidemiology, comparative effectiveness research, health informatics, and data sciences so as to maintain an extensive understanding of external environment, to create opportunities for engagement, and to establish Pfizer as a leader in the field
MD or PhD with at least 3 years' experience in Epidemiology, Data Science, Bioinformatics, a Quantitative Public Health discipline, or related discipline
Demonstrated depth of understanding of observational research methods, regulatory standards, comparative effectiveness research, and ability to leverage epidemiologic and data science expertise to meet evolving business needs
Evidence of technical expertise of applying pharmacoepidemiology evidence and insights at the therapy/product level
Experienced in managing meetings / projects
Extensive expertise in pharmacoepidemiology to advise on disease areas, data, technology, and risk management strategies to development projects and marketed products
Ability to explain strengths and limitations of clinical practice datasets - such as electronic health records, claims, clinical data registries, patient generated health data, and other health data sources - in context of designing pharmacoepidemiology study designs
Candidate 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.
Strong preference for 3 or more years' experience in the pharmaceutical industry; extensive track record interacting with R&D and commercial organizations in pharmaceutical industry
Experience in Oncology and Vaccines preferred
Consulting experience in epidemiologic research a plus
Other Job Details:
Additional Location Information: New York, NY or La Jolla, CA
Eligible for Relocation Package
Eligible for Employee Referral Bonus
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EEO & Employment Eligibility
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