Associate Director, Toxicology (Remote)

Initial Therapeutics, Inc.; United States; Remote; USD 100,000 - 150,000; Full time

Job summary

A leading biopharmaceutical company is seeking a Toxicology expert to manage safety pharmacology and toxicology studies. The role involves leading strategies, ensuring compliance, and contributing to regulatory documents. Candidates should have a Ph.D. and substantial experience in drug development.

Qualifications

• Minimum of 5 years industry experience in drug development.
• Experience with FDA regulatory submissions.
• Ability to design and interpret toxicology studies.

Responsibilities

• Lead toxicology strategy and tactics in development phases.
• Monitor compliance of outsourced studies.
• Write and review regulatory documents.

Skills

Toxicology

Pharmacology

Regulatory Documentation

Project Management

Education

Ph.D. in Toxicology, Pharmacology, or related field

Job description

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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

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