Responsibilities:
- Set toxicology and safety pharmacology strategy across discovery, preclinical, and clinical portfolio; align nonclinical safety plans with development priorities and risk tolerance.
- Represent Toxicology on Research & Early Discovery leadership and other internal/collaboration teams to support portfolio prioritization and program governance.
- Lead and develop the internal Toxicology team (hiring, mentoring, setting priorities).
- Direct design and execution of IND-enabling preclinical pharmacology, PK, mammalian toxicology, and genetic toxicology studies (GLP and non-GLP), ensuring regulatory filing standards.
- Manage Toxicology department budget and resourcing (in-house vs. CRO partners).
- Select and oversee CRO/external partners, including contracting, risk management, and quality oversight for outsourced GLP/non-GLP studies.
- Serve as senior toxicology representative to FDA and other health authorities (IND/CTA/NDA/BLA/MAA submissions and meetings).
- Communicate toxicology findings and risk assessments to program teams, senior management, and the Board.
- Provide toxicology/safety input for business development and due diligence (in-licensing/partnerships).
- Work cross-functionally with Research, CMC, and Clinical to resolve nonclinical safety issues and assess human risk relevance.
- Represent Nurix Toxicology externally with KOLs, industry groups, and regulatory forums.
Required Qualifications:
- Ph.D., M.D., or D.V.M. in Toxicology, Pharmacology, or related discipline.
- 15+ years drug development experience in pharma/biotech; led toxicology/nonclinical safety; advanced multiple programs from IND through Phase IβIII; authored/defended FDA and international regulatory submissions.
- Experience with ADCs and small molecules (strongly preferred).
- Present toxicology/nonclinical safety strategy to senior leadership and external stakeholders (investors/partners).
- People-leadership experience; hiring/management; owned department budget.
- Knowledge of safety pharmacology and toxicology study design compliant with GLP/ICH/FDA/EMA.
- Proven regulatory submission preparation/defense (IND/CTA/NDA/BLA/MAA) with global authorities.
- Business development/due diligence toxicology input experience (preferred).
- Strong communication skills; influence senior leadership; credible external representation.
- D.A.B.T. certification required or strongly preferred.
- Travel as needed.
Salary Range: $360K β $420K
Location: Brisbane, CA (Onsite)