Director, Nonclinical Toxicology Operations

BioSpace

Brisbane (CA)

Vor Ort

USD 221.000 - 253.000

Vollzeit

vor 35 Stunden
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Zusammenfassung

Nurix Therapeutics is seeking a Director of Preclinical Safety and Toxicology Operations to lead nonclinical safety planning, budgets, CRO management, and cross‑functional coordination for degrader programs in Brisbane, CA. The role blends operational support with program management from late lead optimization through IND filing.

You will partner with toxicology leads, project teams, and leadership to develop integrated program plans across chemistry, DMPK, pharmacology, safety, CMC, and

Qualifikationen

  • M.S. or Ph.D. in a life sciences discipline (toxicology, pharmacology, biology, chemistry, pharmaceutical sciences, or related).
  • Preferred: PMP credential.
  • Typically 10+ years in biotech/pharma with project management ownership of multidisciplinary programs.
  • Track record managing CROs and external vendors including contracting, budget tracking, and performance management.
  • Direct experience supporting and coordinating IND‑enabling activities.

Aufgaben

  • Toxicology study support and vendor management.
  • Scope, design, and schedule GLP and non‑GLP safety studies with Toxicology Leads and Study Directors.
  • Identify, qualify, and manage CROs and vendors; coordinate bid processes.
  • Own contract lifecycle: WO, MSAs, changes; track scope vs budget.
  • Build and maintain integrated study timelines and dashboards; escalate slippage.
  • Coordinate protocol and report review cycles and ensure timely approvals.

Kenntnisse

Project management leadership
Cross-functional collaboration
Communication
Agile methodologies

Ausbildung

M.S. or Ph.D. in life sciences
PMP credential

Tools

MS Project
Smartsheet
Planisware
AI tools

Jobbeschreibung

Nurix Therapetics 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 Summary

Nurix Therapeutics is seeking a Director of Preclinical Safety and Toxicology Operations to drive planning and execution of nonclinical safety and toxicology activities within our Research and Early Development division. The role will be responsible for operations activities including owning timelines, budgets, contracts, and cross-functional coordination for a portfolio of targeted protein degradation programs. The ideal candidate will be adept at partnering closely with subject matter experts, preclinical Project Leads, clinical Asset Team Leaders, and the SVP of Preclinical Toxicology who will provide oversight and scientific direction.

The role has two complementary halves. The first is operational support to the nonclinical Safety and Toxicology function — helping study directors and toxicology leads scope and design studies, selecting and managing CROs, negotiating and administering contracts, and keeping study execution on schedule and on budget. The second is program-level project management for drug discovery projects as they transition from late lead optimization through IND filing, integrating chemistry, DMPK, pharmacology, safety, CMC, and regulatory timelines into a single credible plan.

You will thrive here if you are highly organized, scientifically fluent, comfortable holding teams and stakeholders to a schedule, and energized by turning complex, interdependent work into clear milestones and decisions.

Key Responsibilities
  • Toxicology study support and vendor management
  • Partner with Toxicology Leads and Study Directors to scope, design, and schedule GLP and non-GLP in vivo and in vitro safety studies, including exploratory tox, DRF, GLP repeat-dose toxicology, safety pharmacology, and genetic toxicology.
  • Identify, qualify, and manage CROs and specialty vendors; coordinate bid solicitation, bid defense, and vendor selection in partnership with Toxicology, Procurement, and Legal.
  • Own the contract lifecycle: draft and route work orders, MSAs, change orders, and amendments; track scope changes against budget; reconcile invoices and support accruals and forecasting.
  • Build and maintain integrated study timelines; monitor study milestones, sample logistics, bioanalytical turnaround, and report delivery, escalating slippage early with options rather than surprises.
  • Coordinate protocol and report review cycles, ensuring documents move efficiently through internal review, QA, and sign‑off.
  • Track deliverables required for regulatory submissions, including study reports, certificates of analysis, and test article documentation.
  • Demonstrated ability to ensure safety issues are communicated rapidly and with appropriate escalation to the drug safety/project team, leadership and relevant agencies.
  • Program management, late lead optimization to IND
  • Serve as project manager for assigned discovery and development programs from late lead optimization through candidate selection, IND‑enabling studies, and IND filing.
  • Develop and maintain integrated program plans, critical paths, and resource views spanning medicinal chemistry, analytical chemistry, computational chemistry, DMPK, pharmacology, toxicology, CMC, and regulatory.
  • Run project team meetings: set agendas, capture actions and decision rationale in meeting minutes, and follow through to closure.
  • Maintain program dashboards, milestone trackers, and risk registers; surface risks with mitigation and contingency plans.
  • Prepare materials and pre‑reads for portfolio reviews, governance meetings, and leadership updates; ensure a single, consistent version of program status.
  • Coordinate scenario and what‑if planning to support go/no‑go decisions, candidate selection, and IND timing.
  • Cross‑functional leadership and process
  • Act as a connective hub across functions and sites, resolving interface issues before they become timeline issues.
  • Contribute to continuous improvement of project management practices, templates, and tools within the group.
Qualifications
Education
  • Required: M.S. or Ph.D. in a life sciences discipline (toxicology, pharmacology, biology, chemistry, pharmaceutical sciences, or related).
  • Preferred: formal project management credential such as PMP.
Experience
  • Typically, 10+ years of relevant biotech or pharmaceutical experience, including demonstrable project management ownership of multidisciplinary programs.
  • Track record managing CROs and external vendors, including contracting, budget tracking, and performance management.
  • Direct experience supporting and coordinating IND‑enabling activities
  • Working knowledge of small molecule drug discovery and development, nonclinical safety assessment, and GLP requirements, with scientific fluency sufficient to plan, question, and integrate the work.
  • Experience in targeted protein degradation, oncology, or immunology is an advantage.
Skills and attributes
  • Proficiency with project management tools and methods, including integrated timelines, critical path analysis, and resource planning (e.g., MS Project, Smartsheet, Planisware, or equivalent). Familiarity with AI tools a plus.
  • Exceptional organizational skills and attention to detail, with the judgment to know what matters and what does not.
  • Clear, concise written and verbal communication; able to present status and risk to senior leadership without embellishment.
  • Ability to influence and drive accountability without direct authority across a group of senior, highly experienced scientists.
  • Comfort with ambiguity and shifting priorities in a fast‑moving discovery environment.
Reporting and Location

Reporting to SVP of Nonclinical Toxicology, Based At Nurix Therapeutics, Brisbane, CA, with on‑site presence expected to support close partnership with laboratory and program teams.

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

Salary Range: $220,700 - $252,667

Location: Brisbane, CA - Onsite

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