Scientist, Nonclinical Safety and Pathobiology

Gilead Sciences • Foster City, CA

3d • Onsite

About The Position

This Nonclinical Study Monitor role requires an experienced nonclinical safety professional who can independently lead outsourced GLP and non-GLP studies from planning through final report, apply sound toxicology and regulatory judgment, manage CRO execution and cross-functional alignment, and deliver high-quality, inspection-ready study and submission-supporting outputs. The ideal candidate will combine strong scientific and operational ownership with a proactive quality mindset, effective stakeholder communication, and the ability to identify risks, resolve issues, and contribute to continuous improvement across study monitoring and reporting practices.

Requirements

• Bachelor's Degree and Six Years' Experience OR Masters' Degree and Four Years' Experience
• BS or MS degree in toxicology, pharmacology, biology, physiology, veterinary sciences, or a related scientific discipline with significant pharmaceutical, biotechnology, or CRO industry experience
• Direct experience independently monitoring GLP-regulated nonclinical safety studies, preferably across multiple study types, species, therapeutic areas, and modalities.
• Strong understanding of toxicology principles, animal and human biology, physiology, study design, dose selection, toxicokinetics, pathology workflows, and nonclinical development requirements.
• Working knowledge of Good Laboratory Practice regulations and relevant FDA, ICH, EMA, OECD, and other regulatory guidance governing nonclinical safety studies.
• Knowledge of laboratory animal welfare standards, including USDA and AAALAC expectations, and familiarity with IACUC review processes.
• Demonstrated ability to manage CRO relationships, coordinate multiple concurrent studies, anticipate risks, resolve study conduct or reporting issues, and maintain study timelines under tight deadlines.
• Excellent written and verbal communication skills, including the ability to communicate complex study information clearly to scientific, operational, quality, and regulatory stakeholders.
• Strong organizational skills, attention to detail, analytical thinking, sound judgment, and ability to work independently with a high level of logistical planning.
• Proficiency with Microsoft Word, PowerPoint, and Excel; experience with study tracking systems, document management systems, SEND dataset review or visualization tools, and electronic QC workflows is preferred.

Nice To Haves

• Membership or active participation in professional organizations such as ACT or SOT is encouraged.

Responsibilities

• Independently monitor and coordinate outsourced nonclinical safety studies supporting discovery, IND-enabling, and regulatory development programs, including test material planning, analytical testing coordination, shipment logistics, protocol development, dose level selection support, CRO communication, on-site study monitoring, data review, report review, and study archival.
• Serve as lead study monitor for multi-study projects, developing study timelines, identifying critical path activities, troubleshooting formulation or test material issues, and driving timely resolution of operational and scientific questions.
• Lead and coordinate internal and external study meetings with CRO study teams, project toxicologists, study monitors, analytical operations, bioanalytical/toxicokinetic partners, pathology, quality, regulatory, and other cross-functional stakeholders to support complex study logistics and timely execution.
• Review protocols, amendments, raw data summaries, draft reports, final reports, and regulatory-supporting documents for scientific accuracy, internal consistency, compliance with study objectives, and alignment with Gilead expectations and style.
• Coordinate report review cycles, prepare or support study result slides, compile tabulated study summaries, and assist project toxicologists with written or tabulated sections for regulatory documents such as INDs, NDAs, BLAs, and Investigator’s Brochures.
• Perform independent QC review of study protocols, reports, SEND-related outputs, and regulatory submission documents to support high-quality, inspection-ready deliverables.
• Apply expertise in GLP-regulated nonclinical studies, toxicology study conduct, animal welfare expectations, and regulatory guidance to identify risks, recommend solutions, and ensure studies are completed within established timelines.
• Participate in CRO site selection, technical qualification visits, vendor oversight activities, study monitoring visits, and issue escalation as needed.
• Support departmental initiatives, including SOP review, process improvement, harmonization of study templates and reporting practices, vendor oversight enhancements, and onboarding or mentoring of less experienced colleagues.
• Serve as a technical resource or subject matter expert for standard nonclinical study designs, study logistics, CRO interactions, and study monitoring best practices.
• Conduct scientific literature searches and apply findings to study planning, study interpretation, and regulatory support activities.
• Travel as needed for CRO monitoring or qualification activities, typically less than 15%.

Benefits

• company-sponsored medical, dental, vision, and life insurance plans
• discretionary annual bonus
• discretionary stock-based long-term incentives (eligibility may vary based on role)
• paid time off

What This Job Offers

• Job Type: Full-time
• Career Level: Senior