Associate Director, Non-clinical Drug Safety

Associate Director, Non-clinical Drug Safety

Otsuka America Pharmaceutical Inc.
Annapolis, Maryland, 21401

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

• 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

• 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.

Minimum $ - Maximum $, plus incentive opportunity:
The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum.

This information is provided to applicants in accordance with states and local laws.

Final date to receive applications :
This will be posted for a minimum of 5 business days.

• Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement,…