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
We are looking for a collaborative and innovative team member to join 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 Director, Epidemiology Scientist position provides an opportunity for an experienced 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 Director, Epidemiology Scientist 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 incumbent will support multiple GME Vaccine and Hospital activities, including COVID-19 vaccine and anti-viral projects, such as background epidemiology studies, in addition to other therapeutic area epidemiology activities.
This position will report directly to the Epidemiology Strategist, Vaccines and Methods Lead, Global Medical Epidemiology. GME colleagues are located in Collegeville, PA and New York, NY but Pfizer is flexible regarding remote work for the right candidate. ROLE RESPONSIBILITIES
- 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.
- Present and publish results of epidemiological studies at scientific conferences and peer-reviewed journals.
- 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.
- Represent GME within the internal medicine and rare disease therapeutic areas by advocating its importance and building a network of partners.
- Contribute to the continuing education of relevant line functions on the value and impact of epidemiology methods and studies.
- Develop and implement strategic communication plans to educate Pfizer stakeholders of the role and remit of GME.
- Articulate how epidemiology studies can be used to strengthen clinical trial design and facilitate use of accelerated regulatory pathways.
- 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 epidemiology projects atexternal industry conference/workshops.
- Develop effective relationships with external thought leaders in epidemiology, 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.
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.
- PhD with at least 3 years' experience in Epidemiology or another Quantitative Public Health discipline, or MPH with at least 10 years of the above experience.
- Expertise in epidemiology to advise on disease areas, data, technology, and risk management strategies to development projects and marketed products.
- Practical experience with implementation of observational or experimental studies.
- Ability to discern strengths and limitations of real-world datasets - such as electronic health records, claims, clinical data registries, patient generated health data, and other health data sources - in context of designing epidemiology study designs.
- Ability to prioritize and operate in a fast business environment, while not compromising on scientific quality and rigor.
- Change agile and able to manage diverse portfolio of research projects.
- Demonstrated ability to negotiate scientific and operational decisions with cross-functional teams, external collaborators; supports regulatory interactions.
Other Job Details:
- Five or more years experience in the pharmaceutical industry, academia, public health, or other relevant positions following MPH/ PHD/MD degree completion, including experience in regulatory interactions regarding clinical or observational research.
- Experience in safety signal refinement and evaluation.
- Consulting experience in epidemiologic research a plus.
- Demonstrated record of peer-reviewed publications.
Last Date to Apply for Job: February 4th, 2022
Additional Location Information: New York, NY; Collegeville, PA; also open to US remote based for the right candidate
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