Associate Director, Non-clinical Drug Safety

Otsuka Pharmaceutical Companies (U.S.); United States; On-site; USD 169,000 - 253,000; Full time

Benefits offered by this job

Comprehensive medical coverage

401(k) match

Tuition reimbursement

Paid holidays and time off

Disability insurance

Job summary

The Associate Director, Non-clinical Drug Safety at Otsuka America Pharmaceutical Inc. leads nonclinical safety strategies for development programs and provides expert guidance to cross‑functional teams to support program advancement and regulatory objectives.

The role includes preparation of regulatory documents such as INDs, NDAs/BLAs, aggregate reports, fast track designation, and briefing books, while managing outsourcing, timelines, budgets, and risk-based decisions.

Qualifications

• MSc or PhD in Toxicology, Pharmacology or related areas with 7+ years in pharma or CRO.
• DABT is highly desired.
• Strong preference for biologics experience.
• Experience planning and executing nonclinical studies.
• Knowledge of regulatory requirements and drug development.

Responsibilities

• Serve as toxicology SME on cross‑functional teams and guide nonclinical safety decisions.
• Lead IND and NDA enabling GLP toxicology studies.
• Review, analyze and interpret toxicology data and integrate findings into safety assessments.
• Manage outsourcing, timelines, budgets, and deliverables for programs.
• Communicate toxicology findings and risk assessments to teams and leadership.
• Author/co‑author and review regulatory documents.
• Collaborate to implement evolving regulatory guidance in Nonclinical Drug Safety.
• Analyze external scientific knowledge and contribute to improvements.

Skills

Nonclinical safety

Toxicology expertise

Regulatory strategy

Cross-functional leadership

Communication skills

Education

MSc or PhD in Toxicology/Pharmacology or related area

DABT certification (desirable)

Job description

Job Summary

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.

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.

Job Description

• 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 / Required

• 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

Competencies

• Accountability for Results -
• Strategic Thinking & Problem Solving -
• Patient & Customer Centricity -
• Impactful Communication -
• Respectful Collaboration -
• Empowered Development -

Minimum $169,222.00 - Maximum $253,000.00, 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.

Application Deadline

This will be posted for a minimum of 5 business days.

Company 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, and paid leave programs as well as other company provided benefits.

Come discover more about Otsuka and our benefit offerings; https://ah-prod.com/multi/videoplayer/player.html?v=6385356920112.

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.

Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.

If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting [e-mail].

Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. (“Otsuka”) does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka’s application portal without a valid written search agreement in place for the position will be considered Otsuka’s sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.