Associate Director, Toxicology

Job Description

Job Description

Kelly® Science & Clinical is seeking an Associate Director for a direct hire opportunity with one of our clients, a commercial-stage biotechnology company in the San Diego, CA area. If you are driven by the prospect of translating cutting-edge scientific discoveries into tangible advancements and are poised to advance your career, join us as we pioneer progress in the biotechnology industry.
Workplace: San Diego Metropolitan area
Position Title: Associate Director, Toxicology
Salary range: 175,000-250,000/ year
Are you ready to help drive innovation at the cutting edge of RNA-targeted medicine and advanced gene technologies? Our client is renowned for pioneering advances in biotechnology, delivering transformative therapies for serious diseases with a growing portfolio of marketed products and an industry-leading pipeline in neurology, cardiology, and other high-impact areas. Financially robust and passionately patient-focused, we are well positioned to continue shaping the future of RNA medicines and gene editing solutions.
A leading commercial-stage biotechnology innovator, headquartered in the vibrant San Diego area, is seeking a skilled and driven Toxicologist to join its dynamic Preclinical Development team. This role offers the unique opportunity to shape the nonclinical safety strategy for a diverse portfolio of transformative drug candidates. The team thrives on scientific rigor, cross-disciplinary collaboration, and a passion for advancing novel therapies. Onsite presence in Carlsbad, CA is required.
Key Responsibilities

• Serve as the nonclinical safety authority for cross-functional project teams, offering strategic guidance to drive candidate selection, risk assessment, and program progression.
• Design, oversee, and interpret both GLP and non-GLP studies focused on nonclinical pharmacology and toxicology, leveraging external partners for execution.
• Directly manage outsourced studies conducted at CROs, ensuring robust study designs, protocol and report review, proactive issue resolution, and adherence to project timelines.
• Synthesize multidimensional nonclinical datasets—including pharmacology, toxicology, clinical pathology, and TK/PK data—to generate integrated safety assessments.
• Create and implement regulatory and nonclinical toxicology strategies for assigned programs.
• Prepare and critically review nonclinical content for key regulatory submissions (e.g., Investigator’s Brochures, INDs, NDAs, DSURs), and represent the company in global regulatory interactions.
• Evaluate the significance of safety findings and mechanisms of toxicity, ensuring human relevance and impact on development goals.
• Communicate essential nonclinical safety findings, risk evaluations, and implications to internal teams and governance stakeholders.
• Build effective partnerships with both internal colleagues and external collaborators within a matrixed development framework.
• Represent the organization’s interests externally through engagement with scientific meetings, industry consortia, working groups, and professional societies.
• Make meaningful contributions to peer-reviewed scientific publications.

Qualifications

• Advanced degree (Master’s or Ph.D.) in Toxicology or a related life science discipline.
• A minimum of 8 years (with Master’s) or 5 years (with Ph.D.) of experience in nonclinical safety assessment within the pharmaceutical or biotechnology sector.
• Demonstrated expertise in managing and overseeing CRO-conducted studies, with strong skills in protocol/report development and project management.
• Deep experience in generating, integrating, and interpreting toxicological data to inform program decisions.
• Proven ability to author high-quality regulatory documents, including IBs, INDs, CTDs, and other health authority submissions.
• Strong leadership and communication skills, capable of influencing across matrixed R&D environments and engaging senior decision makers.
• Passion for continuous professional growth and the advancement of toxicology expertise.
• DABT certification is preferred.

Why Join Us:
Be a vital part of a trailblazing team where your contributions are valued and impactful. Embrace the opportunity to innovate in a collaborative and forward-thinking environment, advancing the future of treatment for neurological disorders.
If your qualifications align with the requirements of this role, we invite you to apply and take the next step in your career journey. Rest assured, even if this opportunity isn't the perfect match, your profile will remain within our network, ensuring you're connected to a wealth of future opportunities in the field of science and clinical research.
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