Associate Director, Pharmacoepidemiology
- Employer
- Regeneron Pharmaceuticals, Inc.
- Location
- Tarrytown, NY, United States
- Start date
- Sep 19, 2019
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- Discipline
- Regulatory, Regulatory Affairs, Science/R&D, Epidemiology
- Required Education
- Doctorate/PHD/MD
- Position Type
- Full time
- Hotbed
- Pharm Country, Best Places to Work
Job Details
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.
Company
Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye disease, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, infectious diseases, pain and rare diseases.
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune® which produces optimized fully-human antibodies, and ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.
Stock Symbol: REGN
Stock Exchange: NASDAQ
- Website
- https://www.regeneron.com/
- Phone
- 914-847-7000
- Location
-
Corporate Headquarters
777 Old Saw Mill River Road
Tarrytown
New York
10591
United States
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