Temp - Director Pharmacoepidemiology

BioSpace; United States; On-site; USD 180,000 - 260,000; Full time

Job summary

Regeneron is seeking a Director-level Pharmacoepidemiologist to lead the development and implementation of pharmacoepidemiology strategies within the Global Clinical Development organization. You will guide cross-functional teams and epidemiology activities to generate real-world evidence supporting regulatory filings and product development.

You will collaborate with Global Patient Safety, Safety Scientists, Clinical Scientists, Regulatory Affairs, and other partners to deliver timely

Qualifications

• Experience in pharmacoepidemiology and real-world evidence.
• Strong ability to influence decision making within cross-functional teams.
• Experience with regulatory filings and pharmacovigilance processes.

Responsibilities

• Develop and implement pharmacoepidemiology strategy for the designated therapeutic area.
• Lead cross-functional project teams and epidemiology studies to support regulatory filings and approvals.
• Provide epidemiological expertise to GPS Leads, Safety Scientists and Clinical Scientists.
• Draft and maintain SOPs and working instructions; drive process improvements across GPS and Regeneron.
• Manage contractors and external vendors; build collaborations with external experts.

Skills

Strategic thinking

Cross-functional leadership

Epidemiology

Regulatory affairs

Project management

Communication

Education

Bachelor's degree in Biotech/Pharma

Tools

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 organizations efforts to more effectively develop Regenerons product candidates and advance the companys 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.

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 organizations efforts to more effectively develop Regenerons product candidates and advance the companys 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 manage and prioritize multiple tasks and projects with a sense of urgency and to navigate within a matrix organization.
• Experienced in planning and execution; thinks strategically and executes tactically in order to deliver positive results for the business.
• Strong business and financial management acumen.
• Demonstrated resiliency; able and willing to explore different paths to achieve an outcome. Consistently demonstrates good judgment. Takes initiative to bring forward new ideas to improve processes and programs.
• Outstanding verbal and written communication and presentation skills; ability to communicate accurately and concisely
• Education: Minimum of a Bachelors degree and 8+ years of relevant industry related experience in Biotech/Pharma

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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law.

Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining