Associate Scientific Director

Vaga não está no LinkedIn

🕒 Março 10

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $144.000 - $240.000 / 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 clinical pharmacology expertise to program and study teams throughout a molecule’s lifecycle (discovery through development) • Provide functional representation on development programs and study teams and identify opportunities where modeling and simulation can advance the understanding of pharmacological activity, efficacy and safety • Develop & implement the clinical pharmacology development plan, considering all aspects (strategic, scientific, translational, and clinical) • Define key milestones and decisions within the clinical pharmacology development plan and identify risks and mitigation strategies • Lead execution of clinical pharmacology studies & analyses; interpret results and recommend action based on results • Conduct hands-on quantitative analysis and present the findings to multidisciplinary project teams • Serve as lead author and key contributor to clinical pharmacology sections of documents • Serve as the subject matter expert in interactions with Health Authorities • Seek input from and ensure alignment with cross-functional partners, consultants, experts, and vendors as needed • Work with program and/or study teams to achieve program goals and provide deliverables in approved timeframes • Maintain cutting edge knowledge of best regulatory practices, quantitative/clinical pharmacology methodology, and drug development precedent

🎯 Requisitos

• PhD or MD/PhD in Pharmacology, Pharmacokinetics, Pharmaceutics or PharmD or other suitable related fields • 5+ years relevant industry experience (clinical pharmacology and/or clinical PK/PD) • Ability to analyze and interpret PK and PK/PD data utilizing sound scientific principles • Experience with designing and implementing relevant elements of clinical studies and/or dedicated Clinical Pharmacology studies • Ability to develop Clinical Pharmacology strategy in the context of the broader development paradigm • Knowledge of and ability to apply appropriate regulatory and ICH guidelines with regard to the acquisition, analysis, and interpretation of clinical pharmacology data • Hands-on experience with developing and implementing Quantitative Systems Pharmacology (QSP) models, and/or population PK, PKPD, exposure-response analyses • Proficiency with use of PK/PD software packages such as Phoenix, R, NONMEM • Excellent oral and written communication skills for effective interactions in various environments including multidisciplinary teams, regulatory agencies, scientific symposia, and advisory boards

🏖️ Benefícios

• medical, dental, life, long and short-term disability insurances • vacation • end-of-year shutdown • 401K participation and matching contributions • Fitness & Wellness programs including a fitness reimbursement • 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 • Employee stock purchase plan • Tuition reimbursement of up to $10,000 per calendar year