Director, Pharmacoepidemiology

🔥 11 minutes ago

🇺🇸 United States – Remote

⏰ Full Time

🔴 Lead

👔 Director

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Regeneron

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1988

🏥 Healthcare

🏭 Manufacturing

🧬 Biotechnology

💰 Post-IPO Equity on 2023-10

Healthcare • Manufacturing • Biotechnology

Regeneron is a biotechnology company dedicated to turning scientific discoveries into life-changing medicines. The company focuses on a range of serious diseases including allergic, cardiovascular, and metabolic diseases, neuroscience, oncology, hematology, ophthalmology, and rare diseases. It achieves this by integrating biology and technology to develop cutting-edge biologics and genetic medicines. Regeneron is committed to health equity, environmental sustainability, and supporting future STEM talent through initiatives like the Regeneron Science Talent Search. By maintaining high ethical standards and corporate responsibility, Regeneron aims to push the boundaries of science for better healthcare solutions.

📋 Description

• Build productive external partnerships across key areas • Support identification, execution, and management of strategic relationships with organizations and institutions • Coordinate across matrixed teams to identify opportunities and streamline external partnership initiation and maintenance • Build an internal external-partnership capability regarded highly by partners and leaders • Partner with internal leaders working with external partners to ensure collaboration, continuity, and alignment • Develop and implement pharmacoepidemiology strategy in a designated therapeutic area • Lead cross-functional project teams and epidemiology activities, including regulatory agency-required studies • Generate epidemiology data supporting clinical development, regulatory filings, and approvals • Serve as an in-house epidemiology subject matter expert • Generate real-world evidence and conduct post-marketing epidemiologic studies, including PASS, PAES, PMR, DUS, and effectiveness of REMS and RMMs • Contribute to Risk Management Plans, benefit-risk analyses, signal management, regulatory agency responses, and regulatory filings • Provide epidemiological and risk-management strategy and support to project and product teams • Design, implement, and analyze epidemiological studies • Review study proposals from internal and external sources • Explore external electronic patient-level databases, including claims, EMR, surveys, and registries • Represent Pharmacoepidemiology on safety monitoring teams, clinical study teams, safety oversight committees, and independent data monitoring committees • Lead non-compound-specific activities such as literature reviews and database queries • Develop and maintain relevant SOPs and Working Instructions • Drive process improvement activities and strategic initiatives • Manage contractors and external vendors • Develop and maintain professional relationships with external experts and opinion leaders

🎯 Requirements

• Minimum of a Bachelor’s degree • 8+ years of relevant industry-related experience in Biotech/Pharma • Qualifications commensurate with the Director level • Knowledge of the latest epidemiologic methods and resources • 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 in a matrix organization • Experience in planning and execution, with strategic thinking and tactical execution • Strong business and financial management acumen • Proven ability to build consensus with leaders and colleagues • Proven track record of developing and maintaining relationships with partners at all organizational levels • Results-oriented, collaborative style • Demonstrated resiliency, initiative, and good judgment • Outstanding verbal and written communication and presentation skills • Ability to communicate accurately and concisely

🏖️ Benefits

• Annual bonuses or other incentive plans • Equity awards • Pension or retirement benefits • 401(k) company match • Health and wellness programs • Fitness centers • Medical, dental, vision, life, and disability insurance benefits • Paid time off • Family support benefits • Reasonable accommodation for applicants with known disabilities or chronic illnesses during the recruitment process, where required