PhD in Toxicology, Pharmacology, or related field with 10+ years of industry experience, or M.S. with 15+ years.
Extensive experience in small molecules, degraders, and antibody drug conjugates.
Proven ability to design, monitor, and interpret nonclinical toxicology studies.
Experience writing and reviewing regulatory documents (CTA, IND, NDA, etc.) and interacting with regulatory agencies.
Strong decision-making and problem-solving skills in drug development contexts.
Excellent communication skills for conveying complex toxicology issues to stakeholders.
Competency in using NAMs for toxicological evaluations.
Responsibilities
Design and manage exploratory and GLP toxicology studies across various development stages.
Lead toxicology strategy for assessing human risk of novel therapeutic targets.
Implement program-specific toxicology strategies in multi-disciplinary teams.
Monitor outsourced GLP and non-GLP studies for compliance with protocols and regulations.
Write and review toxicology protocols and regulatory documentation.
Provide creative solutions to expedite nonclinical development strategies.
Communicate toxicology study results effectively to project teams and management.
Benefits
Onsite work environment in Brisbane, CA.
Strong team-oriented and collaborative culture.
Focus on solutions and results-oriented approaches.
Encouragement of diverse perspectives and resourcefulness.
Full Job Description
Senior Director, Nonclinical Toxicology
The Opportunity
Design and management of exploratory and GLP toxicology and safety pharmacology studies. Handle multiple projects in a timely and effective manner at various stages of discovery, preclinical, and clinical development. Write, interact, and/or contribute to all applicable Regulatory Documents/Authorities and Asset Teams.
Lead toxicology strategy and tactics in discovery, preclinical development and clinical development with a focus on understanding/assessing the human risk of novel therapeutic targets and/or understanding mode of action for toxicity in nonclinical studies
Participate in multi-disciplinary team efforts and implement program-specific toxicology strategies to support compound and program progression
Monitor outsourced GLP and non-GLP studies ensuring compliance with the protocol, amendments, regulations, safety guidelines, and standard operating procedures
Write and review toxicology protocols, reports, and documentation for regulatory filings, and participate in regulatory interactions
Apply a broad understanding of toxicology, pharmacology, ADME, and knowledge of applicable regulatory guidelines to the design of appropriate toxicology studies and development plans
Provide creative approaches to expedite nonclinical development strategies
Provide a critical review of toxicology study protocols, data and study reports
Serve as the Toxicology representative on multi-functional project teams supporting discovery and development phase projects
Contribute to the preparation of high-quality regulatory documents supporting global clinical development and marketing authorizations
Effectively communicate toxicology study results to project teams and senior level management
Travel required as needed
What You'll Bring
Required Qualifications
PhD in Toxicology, Pharmacology, or a related field with a minimum of 10 years, or M.S. degree with a minimum of 15 years, of pharmaceutical or biotechnology industry experience as part of a drug development project team
Extensive experience in discovery and development of small molecules, degraders, and antibody drug conjugates is desirable
Experience in designing, monitoring and interpreting nonclinical toxicology/safety pharmacology studies
Experience in writing and reviewing nonclinical sections of regulatory documents (CTA, IND, IB, NDA, BLA, etc.) and direct interactions with worldwide regulatory agencies
Extensive drug development experience with strong decision making and problem-solving skills
Excellent written and verbal communication skills, which includes ability to communicate complex toxicology and safety issues clearly to key stakeholders
Experience in health-authority interactions and developing regulatory strategies that require a high degree of scientific and strategic judgments
Competency in incorporating the use of NAMs in toxicological evaluations to strengthen translational decision making
Bonus Qualifications
Board certification in toxicology is highly desired
Salary Range: $312,900 - $344,900
The posted range applies to roles based in the San Francisco Bay Area and reflects local market conditions. Where an offer lands within that range depends on the candidate's relevant experience, technical expertise, and how their background aligns with the role's requirements.
Location: Onsite - Brisbane, CA
Fit with Nurix Culture and Values
Strong team orientation; highly collaborative
Solutions and results-oriented focus
Hands-on approach; resourceful and open to diverse points of view
About Nurix
Nurix Therapeutics is a biotechnology company that is focused on the discovery, development, and commercialization of small molecule therapies that modulate the ubiquitin proteasome system (UPS) for the treatment of cancer and other diseases. The company's proprietary drug discovery platform is based on the use of DNA-encoded libraries (DELs) to identify small molecules that selectively bind to E3 ligases, which are key enzymes in the UPS. Nurix's lead drug candidate, NX-2127, is a first-in-class small molecule inhibitor of the CBL-B E3 ligase that is being developed for the treatment of solid tumors and hematological malignancies. The company was founded in 2013 and is headquartered in San Francisco, California.
