Senior Director, Nonclinical Toxicology

Nurix•Brisbane, CA

4d•Onsite

About The Position

Nurix Therapeutics is seeking a Senior Director, Nonclinical Toxicology to lead toxicology strategy and execution across discovery, preclinical, and clinical development. The role designs and manages exploratory and GLP toxicology and safety pharmacology studies, assesses human risk associated with novel therapeutic targets, and investigates mechanisms of toxicity in nonclinical studies. It manages multiple projects at different development stages and contributes toxicology expertise to multidisciplinary project and asset teams. The Senior Director oversees outsourced GLP and non-GLP studies for compliance with protocols, regulations, safety guidelines, and standard operating procedures. The role writes and reviews study protocols, reports, and regulatory documentation; supports regulatory filings and interactions; and communicates study findings and complex safety issues to project teams and senior management. The position is onsite in Brisbane, California, with travel as needed.

Requirements

PhD in Toxicology, Pharmacology, or a related field with at least 10 years of pharmaceutical or biotechnology industry experience as part of a drug development project team, or an M.S. degree with at least 15 years of such experience.
Experience designing, monitoring, and interpreting nonclinical toxicology and safety pharmacology studies.
Experience writing and reviewing nonclinical sections of regulatory documents, including CTA, IND, IB, NDA, and BLA submissions.
Experience interacting directly with worldwide regulatory agencies.
Extensive drug development experience, with strong decision-making and problem-solving skills.
Excellent written and verbal communication skills, including the ability to clearly communicate complex toxicology and safety issues to key stakeholders.
Experience with health-authority interactions and development of regulatory strategies requiring a high degree of scientific and strategic judgment.
Competency in incorporating new approach methodologies (NAMs) into toxicological evaluations to strengthen translational decision-making.

Nice To Haves

Extensive experience in discovery and development of small molecules, degraders, and antibody drug conjugates.
Board certification in toxicology.

Responsibilities

Design and manage exploratory and GLP toxicology and safety pharmacology studies.
Lead toxicology strategy and tactics across discovery, preclinical development, and clinical development, including assessment of human risk for novel therapeutic targets and investigation of toxicity mechanisms.
Manage multiple projects at various stages of discovery, preclinical, and clinical development.
Participate in multidisciplinary teams and implement program-specific toxicology strategies to support compound and program progression.
Monitor outsourced GLP and non-GLP studies to ensure compliance with protocols, 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 knowledge of toxicology, pharmacology, ADME, and applicable regulatory guidelines to design toxicology studies and development plans.
Develop creative approaches to expedite nonclinical development strategies.
Critically review toxicology study protocols, data, and reports.
Serve as the Toxicology representative on multifunctional project teams supporting discovery- and development-phase projects.
Contribute to high-quality regulatory documents supporting global clinical development and marketing authorizations.
Communicate toxicology study results effectively to project teams and senior-level management.
Travel as needed.