Associate Director, Non-clinical Drug Safety

🕒 July 31

🇺🇸 United States – Remote

💵 $169.2k - $253k / year

⏰ Full Time

🟠 Senior

👔 Director

👻 Ghost score 20%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Otsuka Pharmaceutical Companies (U.S.)

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

💊 Pharmaceuticals

🏥 Healthcare

🧬 Biotechnology

Pharmaceuticals • Healthcare • Biotechnology

Otsuka Pharmaceutical Companies (U. S. ) is a prominent player in the pharmaceutical manufacturing industry, dedicated to creating innovative products for better health worldwide. The company comprises two main entities: Otsuka America Pharmaceutical, Inc. (OAPI), which is focused on commercializing Otsuka-discovered and in-licensed products in North America, and Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC), which specializes in the clinical development and global registration of innovative healthcare solutions, particularly in the field of neuroscience.

📋 Description

• Serve as the toxicology subject matter expert on cross-functional discovery and development teams • 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 toxicology study results • Integrate findings into nonclinical safety assessments and development strategies • Manage outsourcing and study activities, timelines, budgets, and deliverables for assigned programs • Communicate toxicology findings and risk assessments to project teams and senior leadership • Influence program decisions through scientifically sound, risk-based recommendations • Author, co-author, and review 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 evolving regulatory guidance implementation

🎯 Requirements

• MSc or PhD in Toxicology, Pharmacology, or related areas • At least 7 years of experience in a pharmaceutical company or contract research organization • Strong preference for experience in biologics • Strong technical experience 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 • Ability to manage multiple programs simultaneously • Detail-oriented with strong written and verbal communication skills • Diplomate of the American Board of Toxicology (DABT) is highly desired

🏖️ Benefits

• Comprehensive medical, dental, vision, and prescription drug coverage • Company-provided basic life insurance • Accidental death and dismemberment insurance • Short-term and long-term disability insurance • Tuition reimbursement • Student loan assistance • Generous 401(k) match • Flexible time off • Paid holidays • Paid leave programs • Other company-provided benefits • Incentive opportunity