Job Description

Meet is partnered with a globally leading pharmaceutical company on a Scientific Director, Nonclinical Toxicology!

This role involves serving as the nonclinical safety representative for assigned molecules, overseeing the strategy and execution of nonclinical toxicology programs, collaborating with project leads, interpreting data, and authoring regulatory documents. This senior-level role requires scientific expertise in nonclinical safety assessment, knowledge of industry practices and regulatory guidelines, and a vision for innovation in the field.

Location : The position is ideally based in Lake County, IL, near Chicago, with an on-site requirement of at least three days per week. There is flexibility to be located in Northern or Southern California or Massachusetts locations.

Responsibilities :

• Serve as a nonclinical safety subject matter expert on multi-disciplinary project teams.
• Develop and communicate nonclinical safety strategies and plans for various drug modalities (e.g., small molecules, biologics, ADCs, cell and gene therapies) across therapeutic areas (e.g., oncology, neuroscience, immunology).
• Conduct due diligence reviews to assess risks and recommend actions for partnerships or in-licensing.
• Author and submit regulatory documents (e.g., IBs, INDs/CTAs, NDAs/BLAs) and engage with regulatory agencies globally.
• Perform impurity, excipient, and metabolite risk assessments throughout the drug development lifecycle.
• Mentor team members on drug development, focusing on nonclinical aspects.
• Participate in industry consortia addressing nonclinical drug development topics.

Qualifications :

• PhD or DVM required.
• 10+ years of experience leading nonclinical safety programs in the pharmaceutical industry.
• Proven experience authoring regulatory documents and addressing regulatory agency inquiries.
• Expertise in a specific therapeutic area or modality (e.g., gene therapy) is a plus.
• Knowledge of drug metabolism, pharmacokinetics, and safety considerations (e.g., MIST, drug-drug interactions, toxicokinetics, anti-drug antibodies) is beneficial.
• Strong project/program management and leadership skills.
• Proficiency with Microsoft Word, Excel, and PowerPoint.

If you're interested in hearing more about this opportunity please apply or send your resume to carlos.carreiro@meetlifesciences.com

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