Associate Director, Non-clinical Drug Safety

🕒 Julho 31

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Otsuka Pharmaceutical Companies (U.S.)

SiteLinkedInTodas as Vagas

1001 - 5000 funcionários

💊 Farmacêutico

🏥 Saúde

🧬 Biotecnologia

Pharmaceuticals • Healthcare • Biotechnology

As Empresas Farmacêuticas Otsuka (EUA) são um ator proeminente na indústria de fabricação farmacêutica, dedicadas a criar produtos inovadores para uma melhor saúde em todo o mundo. A empresa é composta por duas entidades principais: a Otsuka America Pharmaceutical, Inc. (OAPI), que se concentra na comercialização de produtos descobertos e licenciados pela Otsuka na América do Norte, e a Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC), que é especializada no desenvolvimento clínico e registro global de soluções inovadoras em saúde, particularmente na área de neurociências.

Descrição

• Serve as the toxicology subject matter expert on cross-functional discovery and development teams • Provide strategic nonclinical safety recommendations to support program progression and development decision-making • Lead and oversee IND and NDA enabling GLP toxicology studies • Review, analyze and interpret scientific data and results for toxicology studies • Integrate findings into overall nonclinical safety assessments and development strategies • Manage outsourcing and study activities, study timelines, budgets, and deliverables for assigned programs • Communicate toxicology findings and risk assessments to project teams and senior leadership • Influence program decisions through scientifically sound and risk-based recommendations • Act as author/co-author and reviewer of regulatory documents • Collaborate within the nonclinical team to incorporate new guidance requirements • Analyze competitive scientific knowledge from external sources • Contribute to continuous improvement initiatives and implementation of evolving regulatory guidance within Nonclinical Drug Safety

🎯 Requisitos

• MSc or PhD in Toxicology, Pharmacology or related areas with at least 7 years of experience in a pharmaceutical company or contract research organization • Diplomate of the American Board of Toxicology (DABT) is highly desired • Strong preference to experience in Biologics • Strong technical experience in planning and executing nonclinical studies • Thorough knowledge of regulatory requirements and the overall drug development process • Regulatory expertise preferred, including successful IND/CTA submissions • Ability to switch tasks and priorities as business needs change and manage multiple programs simultaneously • Detail-oriented with strong written and verbal communication skills

🏖️ Benefícios

• Comprehensive medical, dental, vision, prescription drug coverage • Company provided basic life, accidental death & dismemberment • Short-term and long-term disability insurance • Tuition reimbursement • Student loan assistance • A generous 401(k) match • Flexible time off • Paid holidays • Paid leave programs as well as other company provided benefits