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, 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.
Membership or active participation in professional organizations such as ACT or SOT is encouraged.
People Leader Accountabilities:
Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.
Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.
Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem
The salary range for this position is: $146,540.00 - $189,640.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans*.
For additional benefits information, visit:
https://www.gilead.com/careers/compensation-benefits-and-wellbeing
* Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans.
Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex , age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact [email protected] for assistance.
For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law.
Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.
Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.
Please apply via the Internal Career Opportunities portal in Workday.
