5 дней назад
Director, Nonclinical Toxicology Operations (Biotech)
220 700 - 252 667$
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Описание вакансии
Текст:
TL;DR
Director, Nonclinical Toxicology Operations (Biotech): Planning and executing nonclinical safety and toxicology activities for targeted protein degradation programs with an accent on CRO management, study timelines, budgets, contracts, and IND-enabling work. Focus on integrating chemistry, DMPK, pharmacology, toxicology, CMC, and regulatory plans while managing risks, milestones, and cross-functional decisions through IND filing.
Location: Brisbane, California, United States — onsite presence expected
Salary: $220,700–$252,667 per year
Company
is a clinical-stage biopharmaceutical company developing targeted protein degradation medicines for cancer and inflammatory diseases through an AI-integrated discovery engine.
What you will do
- Plan and coordinate GLP and non-GLP in vivo and in vitro safety studies, including exploratory toxicology, dose range finding, repeat-dose toxicology, safety pharmacology, and genetic toxicology.
- Select and manage CROs and specialty vendors, including bids, contracts, work orders, change orders, budgets, invoices, and forecasts.
- Build integrated study timelines, track milestones and deliverables, coordinate reviews, and escalate risks affecting schedules or regulatory submissions.
- Manage discovery and development programs from late lead optimization through candidate selection, IND-enabling studies, and IND filing.
- Integrate chemistry, DMPK, pharmacology, toxicology, CMC, and regulatory plans into critical paths, dashboards, risk registers, and resource views.
- Lead project meetings, portfolio reviews, governance updates, scenario planning, and continuous improvement of project management practices.
Requirements
- M.S. or Ph.D. in toxicology, pharmacology, biology, chemistry, pharmaceutical sciences, or a related life sciences discipline.
- Typically 10+ years of relevant biotech or pharmaceutical experience with ownership of multidisciplinary project management.
- Experience managing CROs and external vendors, including contracting, budget tracking, and performance management.
- Direct experience supporting and coordinating IND-enabling activities, with working knowledge of small-molecule development, nonclinical safety assessment, and GLP requirements.
- Proficiency with integrated timelines, critical path analysis, resource planning, and project management tools such as MS Project, Smartsheet, or Planisware.
- Based in Brisbane, California, with onsite presence required to support laboratory and program teams.
Nice to have
- Formal project management credential such as PMP.
- Experience in targeted protein degradation, oncology, or immunology.
- Familiarity with AI tools.
Culture & Benefits
- Collaborative, highly team-oriented working environment.
- Solutions- and results-oriented approach.
- Hands-on, resourceful culture open to diverse points of view.
- Close partnership with laboratory, program, and senior scientific teams.
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