Director, Pharmacoepidemiology

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 be responsible for leading pharmacoepidemiologic activities and cross-functional project teams to generate epidemiology data in support of clinical development and regulatory filings and approval for the assigned marketed products and/or development compounds and providing consultation as an in-house subject matter expert in epidemiology to other departments.

Responsibilities:

With general support from Head of Pharmacoepidemiology:

1. Responsible for 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 for the assigned marketed products / development compound(s)

2. As a subject matter expert, contribute to other pharmacoepidemiology activities, including but not limited to: (Development) Risk Management Plans; Benefit-Risk analyses; 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 as needed

5. Provide inputs to IIS studies and other epidemiologic consultation on epidemiologic studies to other departments such as Regeneron Genetic Center

6. Participate in the development and maintenance of relevant SOPs and Working Instructions as needed

7. Participate in process improvement activities within Regulatory Affairs as needed

Requirements:

- Doctoral degree in epidemiology or a related field, generally with 5+ years of post-doctoral experience, including 3+ years of industry/regulatory experience.

- Other post-graduate degree in epidemiology (ex. MPH, MSc), generally with 8+ years of experience including 5+ years of industry/regulatory experience.

- Excellent communication and interpersonal skills.

- Demonstrated achievements of increasing complexity/ responsibility.

- 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

- 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.