[Hiring] Associate Director, Non-clinical Drug Safety @Otsuka Pharmaceutical Co., Ltd.

Role Description

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.

• 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.

Qualifications

• 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 for 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.

Requirements

• Accountability for Results - Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
• Strategic Thinking & Problem Solving - Make decisions considering the long-term impact to customers, patients, employees, and the business.
• Patient & Customer Centricity - Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
• Impactful Communication - Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
• Respectful Collaboration - Seek and value others’ perspectives and strive for diverse partnerships to enhance work toward common goals.
• Empowered Development - Play an active role in professional development as a business imperative.

Benefits

• Comprehensive medical, dental, vision, prescription drug coverage.
• Company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance.
• Tuition reimbursement and student loan assistance.
• A generous 401(k) match.
• Flexible time off, paid holidays, and paid leave programs.
• Other company provided benefits.