Associate Director, Pharmacoepidemiology

Location
Tarrytown, NY, United States
Posted
Sep 19, 2019
Ref
17613BR
Required Education
Doctorate/PHD/MD
Position Type
Full time
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.

Summary:
The Associate Director will be responsible for leading pharmacoepidemiologic projects and activities 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.
Responsibilities:
Under supervision of the Pharmacoepidemiology TA lead for Immunology & Inflammation:
1. Responsible for 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 for assigned marketed / development compound(s) or therapeutic areas (TAs)
2. Contribute to other pharmacoepidemologic 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
3. Working closely with Risk Management Leads, Regulatory Affairs, 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
4. 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
5. Participate in the development and maintenance of relevant SOPs and Working Instructions as needed
6. Participate in process improvement activities within Pharmacovigilance & Risk Management (PVRM) as needed
Requirements:
-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 a subject matter expert 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)
This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.

To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.