Director, Pharmacoepidemiology

🕒 Setembro 24

🇺🇸 Estados Unidos – Remoto (EUA)

⏰ Tempo Integral

🔴 Especialista

👔 Diretor

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Regeneron

SiteLinkedInTodas as Vagas

10.000+ funcionários

Fundada em 1988

🏥 Saúde

🏭 Manufatura

🧬 Biotecnologia

💰 Post-IPO Equity em 2023-10

Healthcare • Manufacturing • Biotechnology

A Regeneron é uma empresa de biotecnologia dedicada a transformar descobertas científicas em medicamentos que mudam vidas. A empresa se concentra em uma variedade de doenças graves, incluindo doenças alérgicas, cardiovasculares e metabólicas, neurociência, oncologia, hematologia, oftalmologia e doenças raras. Isso é alcançado integrando biologia e tecnologia para desenvolver biológicos inovadores e medicamentos genéticos. A Regeneron está comprometida com a equidade em saúde, sustentabilidade ambiental e apoio ao talento futuro em STEM por meio de iniciativas como o Regeneron Science Talent Search. Mantendo altos padrões éticos e responsabilidade corporativa, a Regeneron visa ultrapassar os limites da ciência para melhores soluções de saúde.

Descrição

• 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

🎯 Requisitos

• 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

🏖️ Benefícios

• 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