Scientist, Nonclinical Safety and Pathobiology
Gilead Sciences
August 19, 2026
On-site
San Francisco Bay Area
Clinical Research and Development
Job Description
Nonclinical Study Monitor (outsourced GLP and non-GLP)
Responsibilities
- Independently monitor/coordinate outsourced nonclinical safety studies from planning through final report: test material planning, analytical testing coordination, shipment logistics, protocol development, dose-level selection support, CRO communication, on-site monitoring, data review, report review, and archival.
- Lead as study monitor for multi-study projects: timelines, critical-path activities, troubleshoot formulation/test material issues, resolve operational/scientific questions.
- Coordinate study meetings with CRO and cross-functional partners (toxicology, analytics/bioanalytical/toxicokinetic, pathology, quality, regulatory, etc.).
- Review protocols/amendments, raw data summaries, draft/final reports, and regulatory documents for accuracy, consistency, compliance, and alignment.
- Coordinate report review cycles; support slide decks and tabulated summaries; assist in regulatory sections (IND/NDA/BLA/Investigator’s Brochure).
- Perform independent QC review of protocols, reports, SEND outputs, and submission documents.
- Apply GLP/toxicology/animal welfare/regulatory guidance; identify risks and recommend solutions to meet timelines.
- Participate in CRO site selection/qualification, vendor oversight, monitoring visits, and issue escalation.
- Support SOP/process improvement and mentor onboarding.
- Conduct literature searches for planning/interpretation/regulatory support.
- Travel as needed (typically <15%).
Basic Qualifications
- Bachelor’s + 6 years’ experience OR Master’s + 4 years’ experience.
Preferred Qualifications (highlights)
- BS/MS in toxicology/pharmacology/biology/physiology/veterinary sciences (or related).
- Independent GLP-regulated nonclinical safety study monitoring across multiple types/species/areas/modalities.
- Strong toxicology and regulatory knowledge (FDA/ICH/EMA/OECD); animal welfare standards (USDA/AAALAC, IACUC familiarity).
- CRO management, concurrent-study coordination, risk/issue resolution, strong communication, and organization; proficiency in Microsoft Word/PowerPoint/Excel.
People Leader Accountabilities (if applicable)
- Create Inclusion; Develop Talent; Empower Teams.
Compensation/Benefits (as stated)
- Salary range: $146,540–$189,640; may include discretionary bonus, stock-based incentives, paid time off, and company-sponsored medical/dental/vision/life.
Application Instructions
- Current Gilead employees/contractors: apply via Internal Career Opportunities portal in Workday.
Nonclinical Study Monitor (outsourced GLP and non-GLP)
Responsibilities
- Independently monitor/coordinate outsourced nonclinical safety studies from planning through final report: test material planning, analytical testing coordination, shipment logistics, protocol development, dose-level selection support, CRO communication, on-site monitoring, data review, report review, and archival.
- Lead as study monitor for multi-study projects: timelines, critical-path activities, troubleshoot formulation/test material issues, resolve operational/scientific questions.
- Coordinate study meetings with CRO and cross-functional partners (toxicology, analytics/bioanalytical/toxicokinetic, pathology, quality, regulatory, etc.).
- Review protocols/amendments, raw data summaries, draft/final reports, and regulatory documents for accuracy, consistency, compliance, and alignment.
- Coordinate report review cycles; support slide decks and tabulated summaries; assist in regulatory sections (IND/NDA/BLA/Investigator’s Brochure).
- Perform independent QC review of protocols, reports, SEND outputs, and submission documents.
- Apply GLP/toxicology/animal welfare/regulatory guidance; identify risks and recommend solutions to meet timelines.
- Participate in CRO site selection/qualification, vendor oversight, monitoring visits, and issue escalation.
- Support SOP/process improvement and mentor onboarding.
- Conduct literature searches for planning/interpretation/regulatory support.
- Travel as needed (typically <15%).
Basic Qualifications
- Bachelor’s + 6 years’ experience OR Master’s + 4 years’ experience.
Preferred Qualifications (highlights)
- BS/MS in toxicology/pharmacology/biology/physiology/veterinary sciences (or related).
- Independent GLP-regulated nonclinical safety study monitoring across multiple types/species/areas/modalities.
- Strong toxicology and regulatory knowledge (FDA/ICH/EMA/OECD); animal welfare standards (USDA/AAALAC, IACUC familiarity).
- CRO management, concurrent-study coordination, risk/issue resolution, strong communication, and organization; proficiency in Microsoft Word/PowerPoint/Excel.
People Leader Accountabilities (if applicable)
- Create Inclusion; Develop Talent; Empower Teams.
Compensation/Benefits (as stated)
- Salary range: $146,540–$189,640; may include discretionary bonus, stock-based incentives, paid time off, and company-sponsored medical/dental/vision/life.
Application Instructions
- Current Gilead employees/contractors: apply via Internal Career Opportunities portal in Workday.