Director, Epidemiology

Location
Tarrytown, NY
Posted
Nov 16, 2018
Ref
14527BR
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 Director will assume lead role in Epidemiology activities in support of marketed and development compounds of cardiovascular therapeutic area TA . He/she will be accountable for pharmacoepidemiology strategy, leading cross-functional project teams and epidemiology activities such as regulatory agency-required epidemiologic studies and generation of epidemiology data to support clinical development and regulatory filings and approval, and providing consultation as an in-house subject matter expert in epidemiology to other departments . Responsibilities. With oversight from Head of Pharmacoepidemiology . 1. Responsible for pharmacoepidemiology strategy and conduct of regulatory-agency required epidemiologic studies such as PASS, PAES, PMR, DUS, effectiveness of REMS and RMMs in support of clinical development, regulatory filings, and postmarketing requirements. 2. As a subject matter expert, contribute to other pharmacoepidemiology activities, including but not limited to . Development Risk Management Plans . Benefit-Risk analyses . post-approval regulatory agency-required studies . signal management . responses to regulatory agency queries . regulatory filings. 3. Working closely with Regulatory Affairs, Risk Management Leads and other functions, provide timely epidemiological and risk management support to project and product teams of TAs including design, implementation and data analysis of epidemiological studies, review of study proposal from internal and external sources, and database activities such as exploring external electronic, patient-level database s administrative claims/EMR/surveys/registries etc to evaluate safety/benefit questions, mortality and morbidities/comorbidities, and other appropriate epidemiologic data in support of clinical development and regulatory filings. 4. Represent Pharmacoepidemiology on cross-functional teams, including Risk Management Task Force RMTF , Safety Monitoring Teams SMT , Clinical Study Teams including with external partners , Regeneron Safety Oversight Committee, and Independent Data Monitoring Committees. 5. Proactively lead non-compound specific pharmacoepidemiology activities ex. literature review and database queries in support of regulatory filling . 6. Provide inputs to IIS studies and other epidemiologic consultation on epidemiologic studies to other departments such as Regeneron Genetic Center. 7. Actively participate in the development and maintenance of relevant SOPs and Working Instructions. 8. Actively participate. Requirements - Up-to-date knowledge of US, EU, and international regulatory and pharmacovigilance requirements and ability to apply this knowledge to activities for clinical trial and post-marketing environments - Function as a subject matter expert on epidemiology for assigned compounds - Experience utilizing automated healthcare databases internal and large external databases to support pharmacoepidemiologic activities - Significant experience working with external vendors - Doctoral degree in epidemiology, generally with 5+ years of post-doctoral experience, including 3+ years of industry/regulatory experience - MD, plus other post-graduate degree in epidemiology ex. MPH, MSc , generally with 8+ years of experience including 5+ years of industry/regulatory experience - Demonstrated achievements of increasing complexity/ responsibility . 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.