Job Summary:

We are looking for a highly self-motivated individual with extensive experience in the design and management of safety pharmacology, exploratory and GLP toxicology studies. You will be flexible and able to handle multiple projects in a timely and effective manner at various stages of discovery, preclinical and clinical development. You will possess highly organized problem-solving skills and stellar communication, presentation, and critical thinking attributes.

Duties and 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
  • Applying a broad understanding of toxicology, pharmacology, ADME, and knowledge of applicable regulatory guidelines to the design of appropriate toxicology studies and development plans
  • Providing creative approaches to expedite nonclinical development strategies
  • Providing 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
  • Contributing to the preparation of high-quality regulatory documents supporting global clinical development and marketing authorizations
  • Effectively communicating toxicology study results to project teams and senior level management

Required Qualifications:

  • PhD in Toxicology or a related field with a minimum of 6 years of industry experience as part of a drug development project team
  • Certification by the American Board of Toxicology (DABT) is highly desired
  • Substantial nonclinical development experience at a pharmaceutical or biotechnology company
  • Experience in designing, monitoring and interpreting nonclinical toxicology/safety pharmacology studies
  • Experience in writing nonclinical sections of regulatory documents (CTA, IND, IB, NDA, BLA, etc.) and direct interactions with worldwide regulatory agencies
  • A strong scientific knowledge of toxicology
  • A strong working knowledge of US and international regulatory guidelines
  • Familiarity with drug development strategies for small molecules
  • Ability to work independently and in cross-functional team settings, building productive collaborations, managing conflict, and multi-tasking
  • Stellar written and verbal communication skills
  • Demonstrated ability to build and maintain positive relationships with management, peers, external customers, CROs and consultants
  • Strong sense of personal responsibility, creativity and integrity

Company:

Nurix Therapeutics is a biopharmaceutical company focused on the discovery, development and commercialization of small molecule therapies designed to modulate cellular protein levels as a novel treatment approach for cancer and immune disorders. Leveraging Nurix’s extensive expertise in E3 ligases together with its proprietary DNA-encoded libraries, Nurix has built DELigase, an integrated discovery platform to identify and advance novel drug candidates targeting E3 ligases, a broad class of enzymes that can modulate proteins within the cell. Nurix’s drug discovery approach is to either harness or inhibit the natural function of E3 ligases within the ubiquitin proteasome system to selectively decrease or increase cellular protein levels.

Nurix’s wholly owned pipeline comprises targeted protein degraders of Bruton’s tyrosine kinase, a B-cell signaling protein, and inhibitors of Casitas B-lineage lymphoma proto-oncogene-B, an E3 ligase that regulates T cell activation. Nurix is headquartered in San Francisco, California.

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