Job Description
Build our future together:
At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Senior Manager to join our Pharmacoepidemiology team. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide. The Senior Manager will be responsible for managing pharmacoepidemiologic projects and activities with direction in support of marketed and/ or development compounds, commensurate with experience/ skill, in accordance with global regulations and Regeneron SOPs and working practices. Serve as in-house resource on pharmacoepidemiology to other departments. The candidate should 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.
When & where:
Work Location: Remote - United States
25% Travel may be required
Discover your role:
Under supervision of the Pharmacoepidemiology TA lead:
Responsible for implementation of pharmacoepidemiology strategy, generation of real world evidence (RWE), and conduct of regulatory-agency required epidemiologic studies for post-marketing commitments (e.g., PASS, PAES, PMR, DUS, effectiveness of REMS and RMMs) in support of clinical development, regulatory filings, and post-marketing requirements
Actively contribute to other pharmacoepidemiologic activities as a subject matter expert 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
Working closely with Global Patient Safety Leads, Safety Scientists, Regulatory Affairs, Clinical
Scientists and other interested parties, provide timely epidemiological and risk management support to project and product teams including design, implementation and analysis of epidemiological studies, review of study proposals from internal and external sources, reviews of the literature, and database activities such as exploring external electronic, patient-level database(s) (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
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
Manage and/or conduct non-compound specific pharmacoepidemiology activities (ex. literature review and database queries in support of regulatory fillings)
Actively participate in process improvement activities within the department and Global Patient Safety (GPS) as needed
This role requires:
MD, PharmD, plus other post-graduate degree in epidemiology or a related field (e.g. MPH, MSc)
Doctoral degree in epidemiology or a related field, generally with <3 years of relevant post-doctoral experience.
Industry/Regulatory experience preferred.
Other post-graduate degree in epidemiology or a related field (e.g. MPH, MSc), generally with 2+ years of relevant experience. Industry/Regulatory experience preferred
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. 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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.
Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.
Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.
As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.
For jobs in Canada: this posting is for an existing position.
Salary Range (annually)
$150,500.00 - $245,500.00