Associate Director of Nonclinical Safety

Kelly; San Francisco (CA); On-site; USD 200,000 - 230,000; Full time

Job summary

Kelly Science & Clinical is seeking an Associate Director of Toxicology for a clinical-stage biopharmaceutical company in the Los Angeles or San Francisco area. This direct-hire role leads nonclinical safety strategy and advanced toxicology programs to enable transformative pain-management therapies.

The candidate will oversee GLP and IND-enabling studies, manage CRO partnerships, author regulatory sections, and collaborate with Discovery, Regulatory, and Clinical teams to drive data-driven

Qualifications

• Ph.D. in Toxicology, Pharmacology or related discipline (DABT highly preferred).
• ~10+ years of industry experience in nonclinical safety/toxicology.
• Deep expertise in GA/GLP and non-GLP safety studies supporting IND-enabling and late-stage development.
• Regulatory toxicology strategy and experience with GLP/ICH guidelines.
• Experience authoring regulatory submissions and engaging health authorities; CRO management.

Responsibilities

• Act as primary toxicology expert on cross-functional teams shaping nonclinical safety strategies.
• Lead design, oversight, and monitoring of GLP and non-GLP toxicology studies, including IND-enabling work.
• Critically analyze nonclinical safety data and translate findings for development decisions.
• Author nonclinical sections of regulatory documents and coordinate with Regulatory Affairs.
• Collaborate with Discovery, DMPK, Clinical Pharmacology, Clinical Development, and Regulatory teams.

Skills

CRO management

Regulatory strategy

Data interpretation

Cross-functional collaboration

Scientific leadership

Education

Ph.D. in Toxicology, Pharmacology, or related discipline

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