Senior Director, Epidemiology

20 hours ago

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Parexel

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Regulatory and product development consulting • early phase clinical research • phase II-III clinical research • late phase clinical research • eClinical solutions

10,000+ employees

Founded 1983

⚕️ Healthcare Insurance

🧬 Biotechnology

💊 Pharmaceuticals

💰 Venture Round on 1990-01

Description

• The Senior Director Epidemiology leads scientific contribution for epidemiology engagements and real-world studies, providing epidemiology content for proposals, capability presentations, bid-pursuit meetings, protocol development and analysis requirements. • Provides scientific guidance to Sponsors and internal project teams and plays a key role in driving new business opportunities. • Performs as oversight epidemiologist in projects, including in complex projects, taking accountability of supporting lead epidemiologist. • May also perform as lead epidemiologist or as back-up, owning the development of deliverables and leads scientific contribution independently. • Leverages scientific input from other contributors including medical, biostatistics, COA science, and market access. • Leads Parexel’s contribution to industry forums and thought-leadership engagements to advance Parexel’s epidemiology services and market positioning. • Develops and maintains a network of industry professionals and expand their sphere of influence within the industry.

Requirements

• 12+ years’ Epidemiology experience in academia, CROs, biopharmaceutical and/or medical-device industry setting(s), or elsewhere relevant to the position. • Significant experience in the application of expert epidemiologic knowledge to the conceptualization, design and successful delivery of epidemiology services in pharmacoepidemiology, real-world research, risk management and pharmacovigilance. • Experience with key epidemiology study designs (e.g., prospective and retrospective single-cohort and comparative cohort studies, patient and physician surveys, cross-sectional studies). • Remains current with evolution in industry on epidemiology methods, new and innovative study designs, and clinical data sources. • Remains current with regulatory and other industry positions on epidemiologic approaches and real-world evidence. • Requires consulting experience where the candidate added clear value to epidemiologic study design and/or provided an innovative solution to Sponsor’s business needs in real-world evidence generation and/or drug safety. • Demonstrated Thought Leadership and name recognition through published works and industry / scientific presentations. • Comprehensive knowledge of global regulations regarding pharmacovigilance, risk management and safety reporting; drug development; epidemiologic / non-interventional research methodologies; and pharmacoepidemiologic statistical-analysis models. • Experience working with Academic Institutions or Healthcare Providers a plus.