Director, Non-Clinical Drug Safety

Job Summary

The Director, Non-clinical Drug Safety is responsible to manage non-clinical safety and toxicology activities within Early Phase and Translational Medicine (EPTM) group and be responsible of technical and scientific matters related to the design, execution and evaluation of non-clinical safety and toxicology and studies related to internal, external, and early phase assets.  The Director, Non-clinical Drug Safety authors non-clinical summaries related to regulatory submissions and provides technical and scientific oversight at regulatory meetings. The Director, Non-clinical Drug Safety serves as technical expert and functional representative at cross functional development teams, external collaborations, and academic programs.

Job Description

• Manage IND and NDA enabling GLP toxicology studies
• Review, analyze and interpret scientific data and results for toxicology studies
• Evaluate contract research organization or academic laboratories for study placement and manage outsourcing and study activities
• Participate in due diligence activities and serve as non-clinical drug safety expert of external assets
• Plan detailed procedures for defined projects, including timelines, milestones, methodological approaches, expected results and necessary resources
• Act as author/co-author and reviewer of regulatory documents
• Collaborate with Global Pharmacovigilance department in developing a safety strategy for products in development
• Provide regular updates, documentation and communication of project results as appropriate
• Keep current with field of study, including new guidance, tools, and technology development
• Monitor and analyze competitive scientific knowledge from external source
• Serve as technical expert and functional representative at cross functional development teams, external collaborations and academic programs

Qualifications/ Required

Knowledge/ Experience and Skills:

• Strong technical experience planning and executing nonclinical studies
• Thorough knowledge of regulatory requirements and the overall drug development process
• In depth experience with preparation of regulatory documents
• Strong problem solving and creative scientific skills
• Ability to switch tasks and priorities as business needs change and manage multiple programs simultaneously
• Strong written and verbal communication with careful attention to details of presentation
• Demonstrated success in making important decisions and to work under pressure of tight timelines
• Ability to multi-task in a very fast-paced environment
• Strong time management skills and prioritization abilities

Educational Qualifications

• Ph.D. in Toxicology or related areas with at least 5-7 years' experience in a pharmaceutical company or contract research organization. DABT preferred. Strong preference to experience in Genetic Toxicology.

Disclaimer

This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.

Equal Opportunity Employer

Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran or disabled status, or any protected status.

Competencies
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 $183,335.00 - Maximum $274,160.00, plus incentive opportunity: The range shown represents a typical pay range or starting salary for candidates hired to perform the work. Other elemen