Senior Manager, Pharmacoepidemiology
- Employer
- Regeneron Pharmaceuticals, Inc.
- Location
- Basking Ridge, New Jersey
- Start date
- Jun 4, 2023
View more
- Discipline
- Science/R&D, Epidemiology
- Required Education
- Masters Degree/MBA
- Position Type
- Full time
- Hotbed
- Pharm Country, Best Places to Work
Job Details
SUMMARY:
The Senior Manager will be responsible for managing pharmacoepidemiologic projects and activities with direction 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 adaptable within cross functional teams and to guide decision making where needed.
A typical day in this role might include the following...
- Responsible for implementation of pharmacoepidemiology strategy, generation of real world evidence (RWE), and conduct of regulatory-agency required epidemiologic studies for post-marketing commitments (e.g., PASS, PAES, PMR, DUS, effectiveness of REMS and RMMs) in support of clinical development, regulatory filings, and post-marketing requirements
- Actively contribute to other pharmacoepidemiologic 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
- Working closely with Global Patient Safety Leads, Safety Scientists, Regulatory Affairs, Clinical Scientists 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 and regulatory filings
- 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
- Manage and/or conduct non-compound specific pharmacoepidemiology activities (ex. literature review and database queries in support of regulatory fillings)
- Actively participate in process improvement activities within the department and Global Patient Safety (GPS) as needed
This job might be for you if...
- Doctoral degree in epidemiology or a related field
- MD, PharmD, plus other post-graduate degree in epidemiology or a related filed (e.g. MPH, MSc)
- Function as a subject matter expert on pharmacoepidemiology for assigned compounds/projects with proven history of working on diverse and complex matters.
- Knowledge of US and international regulatory guidances (e.g., pharmacovigilance, RWE, good epidemiology practices) and ability to apply this knowledge to pharmacoepidemiology activities throughout the product life-cycle.
- Experience utilizing automated healthcare databases (internal and large external databases) to support pharmacoepidemiologic activities Significant experience working with cross-functional teams and external vendors.
- Excellent written and verbal communication skills
- Track record of interpersonal, leadership, and project management skills
Salary Range (annually)
$141,800.00 - $231,400.00Company
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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