Associate Director, Toxicology

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    "datePosted": "2026-06-16",
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    "description": "<p>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.</p>\n<p> </p>\n<p>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.<br></p>\n<p><br><br></p>\n<p><span style=\"font-weight: bold\"><span style=\"text-decoration: underline\">Key Responsibilities:</span></span></p>\n<p><span style=\"font-weight: bold\">Nonclinical Strategy &amp; Leadership</span></p>\n<ul>\n<li>Serve as the nonclinical safety/toxicology subject matter expert on multidisciplinary project teams</li>\n<li>Provide integrated assessments of nonclinical data and evaluate overall risk/benefit profiles</li>\n<li>Contribute to development candidate selection and overall program strategy</li>\n</ul>\n<p><span style=\"font-weight: bold\">Study Design &amp; Execution</span></p>\n<ul>\n<li>Design, oversee, and monitor nonclinical safety studies, including:\n<ul>\n<li>Exploratory/non-GLP toxicology studies</li>\n<li>IND-enabling toxicology and safety pharmacology studies</li>\n<li>Post-IND studies (e.g., sub-chronic, chronic, reproductive, carcinogenicity)</li>\n</ul>\n</li>\n<li>Manage and oversee CROs and external vendors, including study design, execution, and data quality</li>\n</ul>\n<p><span style=\"font-weight: bold\">Data Analysis &amp; Interpretation</span></p>\n<ul>\n<li>Analyze and interpret nonclinical study data to support program decisions</li>\n<li>Prepare and present findings, and provide guidance to internal stakeholders and governance teams</li>\n<li>Identify data gaps and proactively develop mitigation strategies</li>\n</ul>\n<p><span style=\"font-weight: bold\">Regulatory Support</span></p>\n<ul>\n<li>Author and review nonclinical sections of regulatory documents, including:\n<ul>\n<li>INDs</li>\n<li>Investigator’s Brochures (IBs)</li>\n<li>Briefing books and responses to health authorities</li>\n</ul>\n</li>\n<li>Partner with Regulatory Affairs to support interactions with agencies (e.g., FDA)</li>\n<li>Ensure compliance with GLP, ICH, and applicable regulatory guidelines</li>\n</ul>\n<p><span style=\"font-weight: bold\">Cross-Functional Collaboration</span></p>\n<ul>\n<li>Work closely with Discovery, DMPK, Clinical Pharmacology, Clinical Development, and Regulatory teams</li>\n<li>Contribute to integrated development plans and timelines</li>\n<li>Support portfolio-level decision-making through scientific insight</li>\n</ul>\n<p><span style=\"font-weight: bold\"><br></span></p>\n<p><span style=\"font-weight: bold\"><span style=\"text-decoration: underline\">Qualifications</span></span><br></p>\n<p><span style=\"font-weight: bold\">Education &amp; Experience</span></p>\n<ul>\n<li>PhD in Toxicology, Pharmacology, or related scientific discipline</li>\n<li>DABT board certification is preferred</li>\n<li>~10+ years of industry experience in nonclinical safety/toxicology</li>\n<li>Experience supporting small molecule drug development programs preferred</li>\n<li>Experience with IND-enabling and regulatory toxicology strategies required</li>\n</ul>\n<p> </p>\n<p><span style=\"font-weight: bold\">Core Competencies</span></p>\n<ul>\n<li>Strong scientific judgment and problem-solving capabilities</li>\n<li>Excellent communication and presentation skills</li>\n<li>Ability to work effectively in cross-functional, fast-paced environments</li>\n<li>Collaborative, proactive, and detail-oriented mindset</li>\n</ul>\n<p> </p>\n<p><span style=\"font-weight: bold\">Technical Skills</span></p>\n<ul>\n<li>Strong knowledge of GLP regulations, ICH guidance, and regulatory expectations</li>\n<li>Experience designing, monitoring, and interpreting nonclinical safety studies</li>\n<li>Familiarity with CRO oversight and external vendor management</li>\n</ul>\n<p><br><br></p>\n<p><span style=\"font-weight: bold\">Preferred Qualifications</span></p>\n<ul>\n<li>Experience supporting regulatory submissions and agency interactions</li>\n<li>Background in pain, neuroscience, or related therapeutic areas</li>\n<li>Prior experience in early-stage biotech environments</li>\n</ul>",
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