Temp - Pharmacoepidemiologist
The Pharmacoepidemiologist will be responsible for leading pharmacoepidemiologic Oncology projects and activities. This will support the marketed and/or development compounds commensurate with experience/ skill, in accordance with global regulations and Regeneron SOPs and working practices. We want the candidate to be knowledgeable in the latest epidemiologic methods and resources to be able to be responsive within cross functional teams and to guide decision making where needed.
In this role, a typical day might include the following:
Under supervision of the Pharmacoepidemiology TA lead for Oncology:
Lead the generation of real-world evidence (RWE) in support of the regulatory queries and submissions. Design and conduct of regulatory required epidemiologic studies such as PASS/PMR, PAES, REMS, DUS, and other post-marketing commitments.
Actively contribute to other pharmacoepidemiologic activities for assigned marketed/development compound(s) or TAs, including but not limited to: (Development) Risk Management Plans, Benefit-Risk analyses, post-approval safety studies that may not be required by a regulatory authority, signal management, responses to regulatory agency queries, regulatory filings, safety surveillance and others.
We expect that you will work closely with Risk Management Leads, Regulatory Affairs, and other internal partners to provide timely epidemiologic and risk management support to project and product teams. This will include design, implementation and analysis of epidemiologic studies, review of study proposals from internal and external sources, (administrative claims/EMR/surveys/registries etc) to evaluate safety/benefit questions, disease natural history, and other appropriate epidemiologic data in support of clinical development and regulatory filings
We need help with identification and assessment of external data sources (electronic health care databases, patient registries, others) for their utility in addressing scientific questions in observational Oncology research to support product development and management.
Manage and/or conduct non-compound specific pharmacoepidemiology activities (ex. literature review and database queries in support of regulatory fillings)
Represent Pharmacoepidemiology on cross-functional teams, including Safety Monitoring Teams, Clinical Development Teams (including with external partners), Regeneron Safety Oversight Committee, and Independent Data Monitoring Committees as needed
This role might be for you if:
You have strong understanding of the limitations and strength of real-world data and proven expertise on the design and conduct of epidemiologic studies
Experience in Oncology is a plus
Up-to-date knowledge of US and international regulatory guidances (e.g., pharmacovigilance, RWE, good epidemiology practices). We expect you will apply this knowledge to pharmacoepidemiology activities throughout the product life-cycle and knowledge of the U.S. and ex-U.S healthcare systems and prior experience utilizing automated healthcare databases to support pharmacoepidemiologic activities.
Strong oral and written communication skills and an ability to summarize and present the results of epidemiological studies to different stakeholders with different backgrounds
Ability to work in a highly interactive and cross-functional environment, as well as work independently with limited supervision.
MD, plus other post-graduate degree in epidemiology or a related field (e.g. MPH, MSc)
Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.