This role may be a hybrid role on-site 3 days per week in Basking Ridge, NJ or Tarrytown, NY and 2 days from home OR fully remote.
The Director will be responsible for leading pharmacoepidemiologic projects and activities in the area of oncology, 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 and 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 includes:
- Responsibility 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 contributing to other pharmacoepidemiologic activities as a subject matter authority 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
- Representing 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
- Handling and/or conduct non-compound specific pharmacoepidemiology activities (ex. literature review and database queries in support of regulatory fillings)
- Actively participating in process improvement activities within the department and Global Patient Safety as needed
This job may be for you if you:
- Function as a subject matter authority on pharmacoepidemiology for assigned compounds/projects with proven history of working on diverse and complex matters
- Have op-to-date 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
- Have experience using 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
- Have a consistent record of interpersonal, leadership, and project management skills
To be considered you must have a PhD in Epidemiology with 5+ years of related pharmaceutical industry experience.
Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible employees at all levels!Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.
Salary Range (annually)
$193,200.00 - $322,000.00