Director, Pharmacoepidemiology

Location
Tarrytown, NY
Posted
Mar 25, 2019
Ref
15799BR
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 pharmacoepi activities in support of Eylea and/or development compounds of Opthalmology Theapeutic Area. He/she will be accountable for leading pharmacoepi activities and generation of epi data in support of clinical development, regulatory filing, and commercialization of Eylea/Opthalmology compounds.

Job Duties:

With oversight from Head of Pharmacoepidemiology:
1. Oversee the reviews, management approvals, and submissions of all deliverables (protocol amendments, statistical analysis plans (SAPs), clinical study reports (CSRs), and reponses to regulatory queries) of the ongoing regulatory-agency required pharmacoepi studies
2. Responsible for pharmacoepidemiology strategy and conduct of newly required pharmacoepidemiologic studies such as PASS, PAES, PMR, DUS, effectiveness of REMS and RMMs in support of clinical development, regulatory filings, and post-marketing requirements, including but not limited to preparation of study proposals, clinical concepts, study protocols, SAPs, data analyses, CSRs, and responses to Health Authorities' comments
3. 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
4. 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
5. 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
6. Proactively lead non-compound specific pharmacoepidemiology activities (ex. literature review and database queries in support of regulatory filling such as orphan designation and pediatric study plan)
7. Provide inputs to IIS studies and other epidemiologic consultation on epidemiologic studies to other departments such as Regeneron Genetic Center
8. Actively participate in the development and maintenance of relevant SOPs and Working Instructions
9. Actively participate in process improvement activities within Regulatory Affairs & Pharmacovigilance

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 and epidemiology lead for assigned compounds/TAs

• Experience and expertise in utilizing safety databases (internal and large external databases) to support phrmacoepi activities

• Significant experience working with external vendors
- Doctoral degree in epidemiology
- MD, plus other post-graduate degree in epidemiology (ex. MPH, MSc)
- Doctoral degree in epidemiology, 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.
- 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.