Temp - Director Pharmacoepidemiology

Regeneron Pharmaceuticals, Inc.; United States; On-site; USD 150,000 - 190,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. is seeking a Director-level Pharmacoepidemiologist to lead the development and execution of pharmacoepidemiology strategies within the Global Clinical Development organization.

The role requires collaboration across GPS leads, safety scientists, clinical scientists, and regulatory affairs to generate real-world evidence and support regulatory filings. You will manage cross-functional teams, oversee studies, contribute to SOPs, and build external partnerships to

Responsibilities

• Develop and implement pharmacoepidemiology strategy for the designated therapeutic area (TA).
• Lead cross-functional project teams and epidemiology activities.
• Conduct regulatory agency-required epidemiologic studies for post-marketing commitments.
• Serve as in-house epidemiology SME to other departments.
• Generate real-world evidence to support clinical development and regulatory filings.

Job description

Build our future together:

Within Regeneron, there are a growing number of diverse collaborations and alliances with external entities. This individual will help to build productive external partnerships across several key areas. The Director will support the identification, execution and management of overarching strategic relationships with various organizations and institutions to support the Global Clinical Development organization's efforts to more effectively develop Regeneron's product candidates and advance the company's broader R&D objectives. The individual will function as a strategic and critical thinker, identifying and developing key external relationships and coordinating across a matrix of teams with the purposes of finding opportunities and streamlining external partnership initiation and maintenance. They will be focused on further building an internal capability on behalf of Regeneron that is highly-regarded by external partners and internal leaders. The individual will partner closely with other internal leaders embedded in the company who work with external partners to ensure collaboration, continuity and alignment. This role will be highly collaborative with other functions and will require thoughtful and inclusive leadership. This role will be tasked with not only identifying strategic partnerships, but facilitating the drafting and execution of contracts, as well as remaining connected to the overarching relationships, while helping to facilitate the components that live in specific areas throughout the life of the agreements.

Discover your role:

The Pharmacoepidemiologist with qualifications commensurate with the Director level will be accountable for development and implementation of pharmacoepidemiology strategy in the designated therapeutic area (TA), 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. The Pharmacoepidemiologist will 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.

Under supervision of the Pharmacoepidemiology Therapeutic Area (TA) lead for General Medicines: Responsible for 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

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 with external partners), Regeneron Safety Oversight Committee, and Independent Data Monitoring Committees

Proactively lead non-compound specific pharmacoepidemiology activities (ex. literature review and database queries in support of regulatory filling)

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 GPS and across Regeneron, as appropriate

Manage 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

This role requires:

• A results-oriented, collaborative style.
• Ability to build consensus with leaders and colleagues to gain support for initiatives.
• Proven track record of developing and maintaining relationships with partners at all levels of the organization.
• Previous experience in and deep understanding of the drug development process.
• Ability to manag