Scientist, Nonclinical Safety and Pathobiology

About this role

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.   Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.   We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.

Job Description   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.

Key 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%.

Basic qualifications: Bachelor's Degree and Six Years' Experience OR Masters' Degree and Four Years' Experience Preferred Qualifications: • 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,

Similar jobs

• VP, NonClinical Safety and Pathobiology — Gilead Sciences · Foster City, California, United States
• Director, Nonclinical Safety, Pathology — Gilead Sciences · Foster City, California, United States
• Senior Principal Scientist, Preclinical Safety & Translational Sciences-Translational Pharmacokinetics/Pharmacodynamics — Johnson & Johnson · Spring House, Pennsylvania, United States | San Diego, California, United States
• Assoc. Scientist, Preclinical Dev. — Merck · Rahway, New Jersey, United States
• Senior Director, Safety Pharmacology — GSK · Remote
• Clinical Scientist, Clinical Development — Spyretherapeutics · Remote
• Research Scientist/Engineer, Biological Safety — Anthropic · San Francisco, CA
• Principal Clinical Scientist — Danaher · Chaska, Minnesota, United States | Miami, Florida, United States