Senior Director, Pharmacoepidemiology

Warren, OH - USA

Monthly Salary: $ 242000 - 403300

Posted on: Yesterday

Vacancies: 1 Vacancy

Job Summary

Regeneron Pharmaceuticals is seeking a Senior Director Pharmacoepidemiology to join our team!

In this role a typical day might include:

Reporting to the VP of Global Patient Safety Pharmacoepidemiology (PEPI) this Senior Director role will be accountable to support the designated pharmacoepidemiology therapeutic area lead and leading cross-functional project teams and epidemiology activities such as regulatory agency-required epidemiologic studies and generation of epidemiology data to support clinical development and regulatory filings and approval in accordance with global regulations and Regeneron SOPs and working practices.

Serve as an in-house subject matter expert in epidemiology 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 influence decision making where needed.

This role might be for you if you can/have:

Reporting to the VP of Pharmacoepidemiology:

Responsible for supporting the designated pharmacoepidemiology therapeutic area lead and leading the pharmacoepidemiology strategy and oversight of the generation of real-world evidence (RWE). Additionally responsible for 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.
As a subject matter expert contribute to other pharmacoepidemiology activities including but not limited to: (Development) Risk Management Plans; Benefit-Risk analyses; signal management; responses to regulatory agency queries; regulatory filings.
Working closely with Global Patient Safety (GPS) Leads Safety Scientists Clinical Scientists Regulatory Affairs and other functions provide timely epidemiological and risk management strategy and 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.
Represent Pharmacoepidemiology on cross-functional teams including Safety Monitoring Teams (SMT) Clinical Study Teams (including external partners) Regeneron Safety Oversight Committee and Independent Data Monitoring Committees.
Proactively lead non-compound specific pharmacoepidemiology activities (e.g. literature review and database queries in support of regulatory filing).
Actively drive and participate in the development and maintenance of relevant SOPs and Working Instructions.
Actively drive and participate in process improvement activities and strategic initiatives of GPS and across Regeneron as appropriate.
Manage and/or develop direct report(s) contractors and external vendors as appropriate.
Develop and maintain professional relationships and collaborations with external experts and opinion leaders to ensure high quality evidence generation.

To be considered for this opportunity you must have the following:

Doctoral degree in epidemiology or a related field generally with 8 years of relevant post-doctoral experience with 8 years of Industry/Regulatory experience preferred.
Other post-graduate degree in epidemiology or a related field (e.g. MPH MSc) generally with 10 years of relevant experience with 8 years of Industry/Regulatory experience preferred.
Demonstrated achievements of increasing complexity/responsibility.
Proven history as a subject matter expert in the field of pharmacoepidemiology and ability to represent the function both internally and externally
Up-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.
Experience utilizing automated healthcare databases (internal and large external databases) to support pharmacoepidemiologic activities
Significant experience working with and leading/overseeing cross-functional teams and external vendors.
Proven track record of leadership (e.g. people management and/or project management)
Excellent written and verbal communication skills

#GDPSJobs

Does this sound like you Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits which vary by the U.S. benefits may include health and wellness programs (including medical dental vision life and disability insurance) fitness centers 401(k) company match family support benefits equity awards annual bonuses paid time off and paid leaves (e.g. military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US please visit For other countries specific benefits please speak to your recruiter.
Please be advised that at Regeneron we believe we are most successful and work best when we are together. For that reason many of Regenerons roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regenerons on-site policy and expectations for your role and your location.

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. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment unless the accommodation would impose undue hardship on the operation of the Companys business.

For roles in which the hired candidate will be working in the U.S. the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S Japan or Canada please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity right to work educational qualifications etc.

Salary Range (annually)

$242000.00 - $403300.00

Required Experience:

Exec

Regeneron Pharmaceuticals is seeking a Senior Director Pharmacoepidemiology to join our team!In this role a typical day might include:Reporting to the VP of Global Patient Safety Pharmacoepidemiology (PEPI) this Senior Director role will be accountable to support the designated pharmacoepidemiology ...