Associate Director, Toxicology

We are seeking a highly motivated and experienced Associate Director of Toxicology (Nonclinical Safety) to support the advancement of our pipeline programs. This individual will play a key role in designing, executing, and interpreting nonclinical safety strategies across discovery and development programs. This role will contribute to research and development programs. The successful candidate will serve as a subject matter expert on cross‑functional teams and contribute to regulatory strategy, ensuring that nonclinical programs are scientifically robust and aligned with development timelines. Key Responsibilities Nonclinical Strategy & Leadership Serve as the nonclinical safety/toxicology subject matter expert on multidisciplinary project teams Provide integrated assessments of nonclinical data and evaluate overall risk/benefit profiles Contribute to development candidate selection and overall program strategy Study Design & Execution Design, oversee, and monitor nonclinical safety studies, including: Exploratory/non‑GLP toxicology studies IND‑enabling toxicology and safety pharmacology studies Post‑IND studies (e.g., sub‑chronic, chronic, reproductive, carcinogenicity) Manage and oversee CROs and external vendors, including study design, execution, and data quality Data Analysis & Interpretation Analyze and interpret nonclinical study data to support program decisions Prepare and present findings, and provide guidance to internal stakeholders and governance teams Identify data gaps and proactively develop mitigation strategies Regulatory Support Author and review nonclinical sections of regulatory documents, including: INDs Investigator’s Brochures (IBs) Briefing books and responses to health authorities Partner with Regulatory Affairs to support interactions with agencies (e.g., FDA) Ensure compliance with GLP, ICH, and applicable regulatory guidelines Cross‑Functional Collaboration Work closely with Discovery, DMPK, Clinical Pharmacology, Clinical Development, and Regulatory teams Contribute to integrated development plans and timelines Support portfolio‑level decision‑making through scientific insight Qualifications Education & Experience PhD in Toxicology, Pharmacology, or related scientific discipline DABT board certification is preferred ~10+ years of industry experience in nonclinical safety/toxicology Experience supporting small molecule drug development programs preferred Experience with IND‑enabling and regulatory toxicology strategies required Core Competencies Strong scientific judgment and problem‑solving capabilities Excellent communication and presentation skills Ability to work effectively in cross‑functional, fast‑paced environments Collaborative, proactive, and detail‑oriented mindset Technical Skills Strong knowledge of GLP regulations, ICH guidance, and regulatory expectations Experience designing, monitoring, and interpreting nonclinical safety studies Familiarity with CRO oversight and external vendor management Preferred Qualifications Experience supporting regulatory submissions and agency interactions Background in pain, neuroscience, or related therapeutic areas Prior experience in early‑stage biotech environments #J-18808-Ljbffr