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Senior Study Monitor, Nonclinical Safety and Pathobiology
2 months ago
For Current Gilead Employees and Contractors:
Please log onto your Internal Career Site to apply for this job.
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
Gilead Sciences, Inc. is a research-based biopharmaceutical company headquartered in Foster City, California that discovers, develops, and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead's therapeutic areas of focus include HIV/AIDS, Liver diseases, Oncology, and Inflammation.
Gilead's core values of integrity, inclusion, teamwork, excellence, and accountability shape our culture and are the foundation of our future success. Challenge yourself and make a difference in the world - Being Here Matters.
We are seeking an experienced study monitor to complement our Nonclinical Safety (ie, Toxicology) team. Gilead is a fast-paced, data-driven, scientifically rigorous organization, and the role will suit a scientist who is able to thrive in this type of environment.
Specific Responsibilities:
* Independently monitors and coordinates all aspects of outsourced nonclinical safety studies (eg, calculating test material amounts, determining availability, coordinating analytical testing and shipments, protocol development, dose level selection presentations, on-site CRO monitoring, data and report review, and study archival).
* Independently serves as lead study monitor for IND programs, including responsibilities as described above and creating IND study timelines, leading resolution of formulation/test material issues, schedule internal/external IND kickoff meetings with Monitors and CROs, coordinate report review and support with internal stakeholders, lead CRO IND meetings, coordination of slide preparation of study results, coordinate QC of IND documents.
* Provides knowledge/expertise assisting in management of scientific and technical issues
* Reviews study protocols, data, and reports for scientific content, accuracy, and Gilead style under the guidance of the Project Toxicologist and in accordance with established timelines to meet regulatory requirements
* Prepares study designs, exhibits and/or tables to convey study results and presents within NSP or externally.
* With guidance from the project toxicologist, assists with preparation of tabulated and written sections for regulatory documents (eg, IND, NDA, IB).
* Participates in departmental initiatives such as SOP review, harmonization of templates and reporting styles across contract labs, and updating NSP processes.
* Serves as a technical resource or subject matter expert on standard study designs
* Independently conducts scientific literature searches.
* Out of state travel is required (
