Senior Manager, Pharmacoepidemiology

Regeneron's Global Patient Safety Organization is hiring for a Senior Manager to join the Pharmacoepidemiology team!

In this role, a typical day might include:

• The Senior Manager will be responsible for managing pharmacoepidemiologic projects and activities in support of marketed and/ or development compounds in Ophthalmology/Pain & Neurology 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.

This role might be for you if can:

• 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 in the areas of Ophthalmology/Pain & Neurology.

• 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

To be considered for this opportunity, you must have the following:

• Doctoral degree in epidemiology or a related field

• MD, PharmD, plus other post-graduate degree in epidemiology or a related filed (e.g. MPH, MSc)

#GDPSJobs

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible 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 parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions.  For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process.  Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

Salary Range (annually)