Director, Nonclinical Toxicology Operations
BioSpace - Brisbane, CA
Hiring: Director, Nonclinical Toxicology Operations Company: BioSpace Location: Brisbane, CA Job Posted Time: 2026-09-11 11:44:25 Employment Type: Contract / On-site Target Skills & Keywords : Program Management, Project Management, Vendor Management, tox About the job 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 •Solid functional 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. •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. Required Skills: •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. •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. Qualifications: •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. Compensation: •$220,700 - $252,667 / year Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!