Senior Director, Nonclinical Toxicology

Nurix; Brisbane (CA); Sur place; USD 313 000 - 345 000; Plein temps

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

Toxicology strategy

GLP studies

Regulatory filings

Cross-functional leadership

Regulatory interactions

Communications

Formation

PhD in Toxicology/Pharmacology/related field

MS in related field

Description du poste

Lead toxicology strategy across discovery, preclinical and clinical development at Nurix. As Senior Director, Nonclinical Toxicology, you’ll guide exploratory and GLP safety studies, assess the human risk of novel therapeutic targets, and help shape the regulatory documents that support global clinical development.

Position Description

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

• D. 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 Therapeutics

Nurix Therapeutics is a clinical stage biopharmaceutical company focused on the discovery, development, and commercialization of targeted protein degradation medicines, the next frontier in innovative drug design aimed at improving treatment options for patients with cancer and inflammatory diseases. Powered by a fully AI-integrated discovery engine capable of tackling any protein class, and coupled with unparalleled ligase expertise, Nurix’s dedicated team has built a formidable advantage in translating the science of targeted protein degradation into clinical advancements. Nurix aims to establish degrader-based treatments at the forefront of patient care, writing medicine’s next chapter with a new script to outmatch disease.