About this opportunity
Kelly lists this Associate Director of Nonclinical Safety opportunity in san francisco, California. Review the employer’s description below for duties, qualifications and application requirements.
Job description
Kelly® Science & Clinical is seeking an Associate Director of Toxicology opportunity with one of our clients, a clinical-stage biopharmaceutical company in the Los Angeles, CA area seeking to redefine pain management. 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: Hybrid in the Los Angeles, CA or San Francisco, CA areas
Position Title: Associate Director of Toxicology
Position Type: Direct hire
Salary range: 200,000-230,000/year
About the Company
Join one of the leading clinical-stage biopharmaceutical innovators dedicated to redefining pain management through next-generation, non-opioid therapies. With a culture grounded in scientific rigor, patient-centered innovation, and a track record of executive success, we’re seeking talented individuals to transform care for patients living with pain-related conditions. Our team operates at the forefront of breakthrough science in an environment that values creativity, collaboration, and the advancement of meaningful therapeutics.
Associate Director, Nonclinical Safety (Toxicology)
Are you passionate about advancing innovative therapeutics through strategic toxicology leadership? We are seeking an accomplished and driven Associate Director of Toxicology to shape and deliver nonclinical safety strategies that will enable transformative discovery and development programs. This is a high-impact, visible role-perfect for a scientific leader eager to influence program direction across a dynamic portfolio.
Key Responsibilities
Strategic Leadership & Program Influence
Act as primary toxicology expert on cross-functional teams, shaping nonclinical safety strategies from early discovery through clinical development.
Synthesize and contextualize nonclinical findings to support robust risk-benefit assessments and go/no-go decisions.
Drive candidate selection and portfolio prioritization through deep scientific insight and collaborative partnership.
Study Design & Operational Excellence
Lead the design, oversight, and monitoring of exploratory (non-GLP) and IND-enabling GLP toxicology and safety pharmacology studies, as well as post-IND investigations (e.g., sub-chronic, chronic, reproductive, carcinogenicity studies).
Provide scientific oversight for CROs and external partners, ensuring rigorous execution, high-quality data, and GLP/ICH compliance.
Proactively address data gaps and implement mitigation strategies in fast-evolving development contexts.
Data Analysis & Program Communication
Critically analyze and interpret complex nonclinical safety data, translating findings into actionable recommendations for drug development teams and executive stakeholders.
Present data and strategy with clarity and authority to internal governance bodies and project teams.
Regulatory Strategy & Compliance
Author and review nonclinical sections of key regulatory documents (INDs, IBs, briefing books, responses to agencies), ensuring clarity, completeness, and alignment with global regulatory expectations.
Partner with Regulatory Affairs to drive successful health authority interactions (e.g., FDA), maintaining up-to-date knowledge of guidances and requirements.
Ensure full compliance with GLP, ICH, and other applicable guidelines.
Cross-functional Partnership
Collaborate closely with Discovery, DMPK, Clinical Pharmacology, Clinical Development, and Regulatory teams to deliver seamless and coherent development programs.
Contribute scientific expertise to integrated project plans and portfolio decision-making.
Qualifications
Ph.D. in Toxicology, Pharmacology, or related discipline (DABT highly preferred)
~10+ years of industry experience in nonclinical safety/toxicology, with a demonstrated record of advancing small molecule drug development candidates
Deep expertise in the design, monitoring, and interpretation of GLP and non-GLP safety studies supporting IND-enabling and late-stage development
Command of GLP/ICH regulations and regulatory toxicology strategy
Proven experience authoring regulatory submissions and engaging directly with health authorities
Experience managing CRO relationships and driving data quality in externalized study settings
Background in pain, neuroscience, or related therapeutic areas is advantageous
Prior work in early-stage biotech or high-growth R&D environments preferred
Attributes for Success
Exceptional scientific judgment, analytical rigor, and creative problem-solving
Skilled communicator with a talent for translating complex data into impactful strategy and recommendations
Collaborative, proactive, and highly organized—adept at thriving in cross-functional, fast-paced teams
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Worksite address
san francisco, CA, 94199, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.