Associate Director, Pharmacoepidemiology
The Associate Director will be responsible for leading pharmacoepidemiologic projects and activities supporting marketed and/ or development compounds, in accordance with global regulations and Regeneron SOPs and working practices. We want you to act as in-house resource on pharmacoepidemiology to other departments. We expect you to be knowledgeable in the latest epidemiologic methods and resources and 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 Immunology & Inflammation:
You will generate real-world evidence (RWE) in support of the regulatory queries and submissions. Design and conduct required regulatory epidemiologic studies such as PASS/PMR, PAES, REMS, DUS, and other post-marketing commitments.
Contribute to other activities as an SME including but not limited to: (Development) Risk Management Plans; Benefit-Risk analyses; post-approval safety studies; signal management; responses to regulatory agency queries; regulatory filings, safety surveillance and others.
Work closely with Safety Leads, Regulatory Affairs, and other interested parties. You will provide timely epidemiological and risk management support to project and product teams. This includes:
- 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
Represent Pharmacoepidemiology on cross-functional teams. This includes Safety Monitoring Teams, Clinical Development Teams (including with external partners), Regeneron Safety Oversight Committee, and Independent Data Monitoring Committees.
Participate in process improvement activities within Global Patient Safety as needed.
This role might be for you if:
- Up-to-date knowledge of US and international pharmacovigilance requirements and ability to apply this knowledge to pharmacovigilance activities for clinical trial and post-marketing environments.
- Function as an SME on epidemiology for assigned compounds.
- Experience utilizing safety databases (internal and large external databases) to support epidemiology activities.
- Significant experience working with external vendors
- Doctoral degree in epidemiology or a related field
- MD, plus other post-graduate degree in epidemiology or a related filed (e.g. MPH, MSc)
- Doctoral degree in epidemiology or a related field, generally with 3+ years of relevant post-doctoral experience.
- Other post-graduate degree in epidemiology or a related field (e.g. MPH, MSc), generally with 5+ years of relevant experience.
- Demonstrated achievements of increasing complexity/ responsibility.
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.