Scientist, Nonclinical Safety and Pathobiology
Gilead Sciences · Foster City, CA
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Role summary
Gilead Sciences seeks an experienced nonclinical safety professional to independently oversee outsourced GLP and non-GLP studies from planning through final reporting. The role involves coordinating with contract research organizations, managing study logistics, reviewing protocols and reports for compliance, and ensuring regulatory-ready deliverables across discovery and development programs.
What they're looking for
- Bachelor's degree and six years of experience, or Master's degree and four years of experience
- Independent monitoring experience with GLP-regulated nonclinical safety studies across multiple types
- Strong toxicology principles knowledge and understanding of animal biology and study design
- Working knowledge of FDA, ICH, EMA, OECD regulations and Good Laboratory Practice requirements
- Familiarity with laboratory animal welfare standards and IACUC review processes
- Ability to manage CRO relationships and coordinate multiple concurrent studies effectively
- Excellent written and verbal communication skills for diverse scientific and operational stakeholders
What you'll be doing
- Monitor and coordinate outsourced nonclinical safety studies including protocol development, data review, and report archival
- Lead study monitoring for multi-study projects, managing timelines and resolving formulation or material issues
- Coordinate internal and external meetings with CRO teams, toxicologists, and cross-functional partners
- Review protocols, amendments, raw data summaries, and regulatory documents for scientific accuracy and compliance
- Perform quality control review of study protocols, reports, and submission documents for inspection readiness
Privacy & handoff
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