Associate Director of Toxicology

Description
Kelly Science & Clinical is seeking an Associate Director of Toxicology 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: ,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.

• 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.

• 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.

Be a vital part of a trailblazing team where your contributions are valued and impactful. Embrace the opportunity to…