Senior Director, Nonclinical Toxicology & Safety

Kelly; San Francisco (CA); Hybrid; 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 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