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About the Role
This role supports the identification, execution, and management of strategic relationships with external organizations to advance Regeneron's Global Clinical Development and broader R&D objectives. The individual will act as a strategic thinker, developing key external relationships and coordinating across teams to streamline partnership initiation and maintenance, building a highly-regarded internal capability.
Responsibilities
- Develop and implement pharmacoepidemiology strategy in the designated therapeutic area.
- Lead cross-functional project teams and epidemiology activities, including regulatory agency-required studies and generation of data for clinical development and regulatory filings.
- Serve as an in-house subject matter expert in epidemiology to other departments.
- Generate real-world evidence (RWE) and conduct regulatory agency-required epidemiologic studies for post-marketing commitments.
- Contribute to risk management plans, benefit-risk analyses, signal management, and responses to regulatory agency queries.
- Provide epidemiological and risk management strategy and support to project and product teams.
- Design, implement, and analyze epidemiological studies, and review study proposals.
- Explore external electronic, patient-level databases to evaluate safety/benefit questions.
- Represent Pharmacoepidemiology on cross-functional teams, including Safety Monitoring Teams and Clinical Study Teams.
- Lead non-compound specific pharmacoepidemiology activities, such as literature reviews and database queries.
- Drive and participate in the development and maintenance of relevant SOPs and Working Instructions.
- Participate in process improvement activities and strategic initiatives.
- Manage contractors and external vendors.
- Develop and maintain professional relationships and collaborations with external experts and opinion leaders.
Requirements
- Results-oriented, collaborative style.
- Ability to build consensus with leaders and colleagues.
- Proven track record of developing and maintaining relationships with partners at all levels.
- Deep understanding of the drug development process.
- Ability to manage and prioritize multiple tasks and projects with a sense of urgency.
- Ability to navigate within a matrix organization.
- Experienced in planning and execution; thinks strategically and executes tactically.
- Strong business and financial management acumen.
- Demonstrated resiliency and willingness 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.
Skills
- Pharmacoepidemiology
- Real-world evidence (RWE) generation
- Epidemiologic study design, implementation, and analysis
- Risk management plans
- Benefit-Risk analyses
- Signal management
- Regulatory filings
- Database activities (administrative claims/EMR/surveys/registries)
- Contract drafting and execution
- Relationship management
- Strategic thinking
- Cross-functional collaboration
- Process improvement
Location
- On-site (specific expectations to be discussed with recruiter and hiring manager)
Work Type
- Full-time
- On-site
Experience Level
- Director level
- 8+ years of relevant industry related experience
Education Level
- Bachelors degree
Salary/Compensations
- Salary ranges are disclosed where required and determined by country, role level, skills, and experience. A competitive and comprehensive total rewards package is offered.
Benefits
- Annual bonuses or other incentive plans
- Equity awards
- Pension or retirement benefits
- 401(k) company match
- Health and wellness programs
- Fitness centers
- Insurance benefits (medical, dental, vision, life and disability)
- Paid time off
- Family support benefits
About the Company
- Regeneron is committed to building a workplace with an inclusive culture.
- Regeneron believes in doing our best work when we are together.
Equal Opportunity
- 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.