[Remote] Associate Director, Non-clinical Drug Safety

Note: The job is a remote job and is open to candidates in USA. Otsuka Pharmaceutical Development and Commercialization, Inc. is a pharmaceutical company developing small molecules and biologics. The Associate Director, Non-clinical Drug Safety leads nonclinical safety strategies, oversees toxicology studies, evaluates scientific data, and provides guidance to cross-functional teams. The role also supports regulatory submissions and communicates risk assessments to project teams and senior leadership.

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

Skills

• MSc or PhD in Toxicology, Pharmacology or related areas
• 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
• Strong written and verbal communication skills
• Diplomate of the American Board of Toxicology (DABT)
• Experience in Biologics
• Regulatory expertise
• Successful IND/CTA submissions

Benefits

• Comprehensive medical, dental, vision, prescription drug coverage
• Company provided basic life insurance
• Accidental death & dismemberment insurance
• 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

Company Overview

Company H1B Sponsorship