Senior Director, Nonclinical Toxicology

Nurix•Brisbane, CA

19h•Onsite

About The Position

The Senior Director, Nonclinical Toxicology leads toxicology strategy and execution across discovery, preclinical development, and clinical development. The role designs and manages exploratory and GLP toxicology and safety pharmacology studies, supports multiple programs at different stages, and assesses human risk associated with novel therapeutic targets and potential toxicity mechanisms. The position represents Toxicology on multidisciplinary project teams and develops program-specific strategies to support compound and program progression. It oversees outsourced GLP and non-GLP studies for compliance with protocols, regulations, safety guidelines, and standard operating procedures; writes and reviews study protocols, reports, and regulatory documentation; and participates in regulatory interactions. The role applies knowledge of toxicology, pharmacology, ADME, and regulatory guidance to design studies and development plans, communicates results to project teams and senior management, and contributes to regulatory documents supporting global clinical development and marketing authorizations. Travel is required as needed. This is an onsite position in Brisbane, California. Nurix describes its culture as collaborative, solutions- and results-oriented, hands-on, resourceful, and open to diverse points of view.

Requirements

PhD in Toxicology, Pharmacology, or a related field with at least 10 years of pharmaceutical or biotechnology industry experience on a drug development project team; alternatively, 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, such as CTA, IND, IB, NDA, and BLA submissions, and interacting directly with worldwide regulatory agencies.
Extensive drug development experience and strong decision-making and problem-solving skills.
Excellent written and verbal communication skills, including the ability to clearly explain complex toxicology and safety issues to key stakeholders.
Experience with health-authority interactions and developing 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.
Strong team orientation and collaborative approach.
Solutions- and results-oriented focus.
Hands-on, resourceful approach and openness to diverse points of view.

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 assessing human risk from novel therapeutic targets and investigating toxicity mechanisms.
Develop and implement program-specific toxicology strategies to support compound and program progression as part of multidisciplinary teams.
Monitor outsourced GLP and non-GLP studies for 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 regulatory guidelines to design appropriate 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 projects.
Contribute to high-quality regulatory documents supporting global clinical development and marketing authorizations.
Communicate toxicology study results effectively to project teams and senior management.
Travel as needed.