Associate Director, Toxicology
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.
Position
Design and management of safety pharmacology, exploratory and GLP toxicology 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.
Responsibilities
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
Serve as the internal study directory and primary point-of-contact with CRO partners, interacting with technical, veterinary, and scientific staff
Monitor outsourced GLP and non-GLP studies ensuring compliance with the protocol, amendments, regulations, safety guidelines, and standard operating procedures
Write and review toxicology 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.
Required Qualifications
Ph.D. in Toxicology, Pharmacology, or a related field with a minimum of 5 years of industry experience as part of a drug development project team or a minimum of 5 years FDA experience reviewing nonclinical regulatory submissions
Substantial nonclinical development experience at a pharmaceutical or biotechnology company or with the FDA
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
Bonus Qualifications
Certification by the American Board of Toxicology (DABT) is highly desired
Nurix Therapeutics, Inc. is committed to protecting and respecting your privacy and personal information, including information collected by Nurix when you apply for a job with Nurix or in the course of your employment with Nurix. By applying for a position at Nurix, you agree to our collection and use of personal information as described in our Privacy Policy (https://www.nurixtx.com/privacy-policy/).
Apply Now
Position
Design and management of safety pharmacology, exploratory and GLP toxicology 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.
Responsibilities
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
Serve as the internal study directory and primary point-of-contact with CRO partners, interacting with technical, veterinary, and scientific staff
Monitor outsourced GLP and non-GLP studies ensuring compliance with the protocol, amendments, regulations, safety guidelines, and standard operating procedures
Write and review toxicology 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.
Required Qualifications
Ph.D. in Toxicology, Pharmacology, or a related field with a minimum of 5 years of industry experience as part of a drug development project team or a minimum of 5 years FDA experience reviewing nonclinical regulatory submissions
Substantial nonclinical development experience at a pharmaceutical or biotechnology company or with the FDA
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
Bonus Qualifications
Certification by the American Board of Toxicology (DABT) is highly desired
Nurix Therapeutics, Inc. is committed to protecting and respecting your privacy and personal information, including information collected by Nurix when you apply for a job with Nurix or in the course of your employment with Nurix. By applying for a position at Nurix, you agree to our collection and use of personal information as described in our Privacy Policy (https://www.nurixtx.com/privacy-policy/).
Apply Now