Associate Director, Non-clinical Drug Safety

Otsuka Pharmaceutical Co., Ltd.

14d • $169,222 - $253,000

About The Position

The Associate Director, Non-clinical Drug Safety is responsible for technical and scientific matters related to the design, execution and evaluation of non-clinical safety and toxicology for small molecules and biologics. The role independently leads nonclinical safety strategies for assigned development programs and provides expert scientific guidance to cross-functional teams to support program advancement and regulatory objectives. This includes the preparation of regulatory documents such as INDs, NDAs/BLAs, aggregate reports, fast track designation, 8-FA, ICFs, and briefing books.

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
• Strong technical experience in planning and executing nonclinical studies
• Thorough knowledge of regulatory requirements and the overall drug development process
• Ability to switch tasks and priorities as business needs change and manage multiple programs simultaneously
• Detail-oriented with strong written and verbal communication skills

Nice To Haves

• Diplomate of the American Board of Toxicology (DABT) is highly desired.
• Strong preference to experience in Biologics
• Regulatory expertise preferred, including successful IND/CTA submissions

Responsibilities

• Serve as the toxicology subject matter expert on cross-functional discovery and development teams and 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 and 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, influencing 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, scientific standards, and implementation of evolving regulatory guidance within Nonclinical Drug Safety

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

What This Job Offers

• Job Type: Full-time
• Career Level: Manager