Regeneron Pharmaceuticals
Senior Director, Pharmacoepidemiology
Regeneron Pharmaceuticals, Warren, Michigan, United States, 48091
Overview
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.
Responsibilities
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.
Qualifications
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 guidance’s (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 location. In 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 https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries’ specific benefits, please speak to your recruiter.
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 Company's business.
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)
$242,000.00 - $403,300.00
#J-18808-Ljbffr
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.
Responsibilities
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.
Qualifications
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 guidance’s (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 location. In 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 https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries’ specific benefits, please speak to your recruiter.
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 Company's business.
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)
$242,000.00 - $403,300.00
#J-18808-Ljbffr