Associate Director, Non-clinical Drug Safety

🔥 29 minutes ago

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Otsuka Pharmaceutical Companies (U.S.)

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

💊 Pharmaceuticals

🏥 Healthcare

🧬 Biotechnology

Pharmaceuticals • Healthcare • Biotechnology

Otsuka Pharmaceutical Companies (U. S. ) is a prominent player in the pharmaceutical manufacturing industry, dedicated to creating innovative products for better health worldwide. The company comprises two main entities: Otsuka America Pharmaceutical, Inc. (OAPI), which is focused on commercializing Otsuka-discovered and in-licensed products in North America, and Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC), which specializes in the clinical development and global registration of innovative healthcare solutions, particularly in the field of neuroscience.

📋 Description

• 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

🎯 Requirements

• 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

🏖️ Benefits

• 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