Auto req ID: 1985BR
Job Posting Title: Director, Pharmacoepidemiology
Person Type: Regular
Posting Category: Clinical Development & Regulatory Affairs
Job Summary and Essential Functions:
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 markets medicines for eye diseases, colorectal cancer, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including hypercholesterolemia, oncology, rheumatoid arthritis, allergic asthma, and atopic dermatitis.
Responsible for leading pharmacoepidemiologic activities in support of marketed and development compounds. Take initiative/ assume lead role in relevant across-compound activities. Serve as in-house expert on pharmacoepidemology to other departments. May assume personnel management responsibilities.
1. With oversight from Head of PVRM, responsible for leading pharmocoepidemiologic activities for marketed and development compounds including and not limited to contributions to: (Development) Risk Management Plans; Benefit-Risk analyses; post-approval safety studies; signal management; responses to regulatory agency queries; regulatory filings
2. Work closely with Risk Management Leads and other interested parties on activities related to external databases. Take the lead in interactions with representatives of these databases to determine search criteria and analyses that will be required to obtain the desired information.
3. Represent Pharmacoepidemiology on cross-functional teams, including Safety Management Teams, Clinical Development Teams (including with external partners), Regeneron Safety Oversight Committee, and Independent Data Monitoring Committees
4. Proactively lead non-compound specific pharmacoepidemiology activities (ex. natural history of disease; assessing burden of disease)
5. As PVRM responsibilities permit, support relevant activities for other departments such as Health Economics and Outcome Research, Clinical Research, or Medical Affairs.
6. Actively participate in the development and maintenance of relevant SOPs and working practices
7. Actively participate in process improvement activities within PVRM
8. Requires the ability to influence outcomes and change the thinking of, or gain acceptance of others in sensitive situations.
9. Contributes to the completion of organizational projects and goals.
10. Errors in judgment or failure to achieve results would normally require a moderate expenditure of resources to rectify.
11. Regularly interacts with Sr. Management or Executive levels on matters concerning specific compounds or problems.
Experience and Required Skills:
-Function as a subject matter expert internal and external to PVRM for pharmacoepidemiology.
-Strong knowledge and familiarity with large external databases.
-Ability to apply relevant FDA, EU and ICH guidelines, initiatives and regulations governing pharmacovigilance activities for both clinical trial and post-marketing environment.
-Ability to effectively communicate (verbal and written) and defend findings and recommended strategies and activities to address these findings.
Minimal Educational Requirements & Minimum Years Experience
-PhD in epidemiology: with 8+ years of experience in pharmacoepidemiology, including at least 4 years of industry experience.
-Demonstrated achievements of increasing complexity/ responsibility (PASS; REMS; RMPs).
-Experience with leading searches of large external databases (ex. FAERS) and appropriately interpreting the results.
-Other post-graduate degree in epidemiology (MPH; MSc): As above with the exception of: at least 12 years of experience in pharmacoepidemiology, including at least 4 years of industry experience.
*If based in Basking Ridge, must be on-site in Tarrytown at least one day/ week.
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
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.