Associate Scientific Director, Pharmacometrics

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🕒 Março 23

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $167.000 - $230.000 / ano

⏰ Tempo Integral

🔴 Especialista

👔 Diretor

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Biogen

SiteLinkedInTodas as Vagas

5001 - 10000 funcionários

🏥 Saúde

🏭 Manufatura

🧬 Biotecnologia

Healthcare • Manufacturing • Biotechnology

A Biogen é uma empresa de biotecnologia dedicada à descoberta, desenvolvimento e fornecimento de terapias inovadoras para pessoas que vivem com doenças neurológicas graves, incluindo a doença de Alzheimer, esclerose múltipla e atrofia muscular espinhal. Com forte ênfase em pesquisa e desenvolvimento, a Biogen continua a avançar na ciência da neurologia por meio de ensaios clínicos e parcerias estratégicas, enquanto também se esforça para garantir acesso e equidade em saúde no setor de saúde.

Descrição

• Provide pharmacometrics expertise to activities throughout the drug development lifecycle and effectively collaborate with cross functional teams • Execute advanced pharmacometrics analyses, with emphasis on PK/PD modeling and simulation and exposure-response analysis for high priority programs • Identify opportunities where modeling and simulation can advance the understanding of pharmacokinetics, pharmacodynamics, efficacy and safety • Contribute to Model Informed Drug Development (MIDD) activities to support dose selection, regimen optimization and clinical trial design • Communicate the pharmacometrics analysis results to program teams to support data-driven decision-making process • Mentor and guide Clinical Pharmacology and Pharmacometrics colleagues on pharmacometrics analyses methodologies • Serve as a lead author and key contributor for pharmacometrics sections of clinical and regulatory documents • Publish in scientific journals and present at internal and external scientific events

🎯 Requisitos

• PhD in Pharmacology, Pharmacokinetics, Pharmaceutics or a related quantitative discipline. • 5+ years of relevant industry experience applying population PK/PD and other advanced quantitative methodologies to decision making • Deep and extensive experience with advanced population PK/PD methodology • Strong understanding of the clinical pharmacology principles and methodologies and their application in drug development • Solid knowledge of the drug development process and regulatory expectations for pharmacometrics analyses • Ability to interpret quantitative results and translate analyses into actionable program insights • Hands-on experience with pharmacometrics software tools such as NONMEM, Monolix, and R. • Experience with mechanistic or systems pharmacology models is a plus.

🏖️ Benefícios

• Medical, Dental, Vision, & Life insurances • Fitness & Wellness programs including a fitness reimbursement • Short- and Long-Term Disability insurance • A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31) • Up to 12 company paid holidays + 3 paid days off for Personal Significance • 80 hours of sick time per calendar year • Paid Maternity and Parental Leave benefit • 401(k) program participation with company matched contributions • Employee stock purchase plan • Tuition reimbursement of up to $10,000 per calendar year • Employee Resource Groups participation