Senior Director, Nonclinical Toxicology — Strategy Lead

Nurix; Brisbane (CA); On-site; USD 313,000 - 345,000; Full time

Job summary

Nurix Therapeutics in Brisbane, CA is seeking a Senior Director, Nonclinical Toxicology to lead exploratory and GLP safety studies across discovery to clinical development. You will design programs, interact with global regulatory agencies, and guide human risk assessment of novel targets.

Responsibilities include writing regulatory documents, monitoring outsourced studies, and providing toxicology leadership on multi-disciplinary teams to support regulatory filings and program progression.

Qualifications

• PhD in Toxicology, Pharmacology, or related field with a minimum of 10 years in pharma/biotech drug development.
• MS with a minimum of 15 years of pharmaceutical/biotech industry experience on drug development teams.
• Experience in discovery to clinical development of small molecules, degraders, and ADCs is desirable.
• Experience writing nonclinical sections of regulatory documents (CTA, IND, IB, NDA, BLA, etc.).
• Strong decision making and problem-solving skills; excellent written and verbal communication.
• Experience with health-authority interactions and regulatory strategy development.
• Knowledge of NAMs in toxicology evaluations is a plus.

Responsibilities

• Design and management of exploratory and GLP toxicology and safety pharmacology studies.
• Lead toxicology strategy across discovery, preclinical and clinical development.
• Interact with Regulatory Documents/Authorities and Asset Teams.
• Monitor outsourced GLP and non-GLP studies for compliance.
• Prepare and review toxicology protocols and reports for regulatory filings.

Skills

Toxicology strategy

GLP studies

Regulatory filings

Cross-functional leadership

Regulatory interactions

Communications

Education

PhD in Toxicology/Pharmacology/related field

MS in related field

Job description

Nurix Therapeutics in Brisbane, CA is seeking a Senior Director, Nonclinical Toxicology to lead exploratory and GLP safety studies across discovery to clinical development. You will design programs, interact with global regulatory agencies, and guide human risk assessment of novel targets.

Responsibilities include writing regulatory documents, monitoring outsourced studies, and providing toxicology leadership on multi-disciplinary teams to support regulatory filings and program progression.