Gilead Sciences, Inc.
Senior Study Monitor, Nonclinical Safety and Pathobiology
Gilead Sciences, Inc., Foster City, California, United States, 94420
Senior Study Monitor, Nonclinical Safety and PathobiologyGilead 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.
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 ( Additional responsibilities may include CRO site selection/technical qualification visits, SEND dataset review/visualization.
Knowledge, Experience and Skills:
BS or MS degree in related scientific discipline with 6+ (MS) or 8+ (BS) years of pharmaceutical or CRO industry experience in small molecule and/or biopharmaceutical drug development.
Knowledge of the general principles and methods of toxicology, animal and human biology and physiology is required.
Experience with both small molecule modalities and biologics.
Direct experience with GLP-regulated studies, GLPs and knowledge of FDA/ICH/EMA guidance governing the conduct of nonclinical safety studies is required.
Knowledge of laboratory animal welfare standards (USDA, AALAC, etc.) and familiar with IACUC review.
Excellent verbal and written communication skills, analytical skills, interpersonal skills, teamwork and decision-making skills are required.
Strong organization skills and attention to detail, along with the ability to prioritize multiple tasks and plan proactively to achieve goals with tight timelines is required.
Able to work independently with a high level of logistical planning.
Membership in ACT/SOT encouraged.
The salary range for this position is: $143,225.00 - $185,350.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. 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:
Gilead Benefits .
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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 ( Additional responsibilities may include CRO site selection/technical qualification visits, SEND dataset review/visualization.
Knowledge, Experience and Skills:
BS or MS degree in related scientific discipline with 6+ (MS) or 8+ (BS) years of pharmaceutical or CRO industry experience in small molecule and/or biopharmaceutical drug development.
Knowledge of the general principles and methods of toxicology, animal and human biology and physiology is required.
Experience with both small molecule modalities and biologics.
Direct experience with GLP-regulated studies, GLPs and knowledge of FDA/ICH/EMA guidance governing the conduct of nonclinical safety studies is required.
Knowledge of laboratory animal welfare standards (USDA, AALAC, etc.) and familiar with IACUC review.
Excellent verbal and written communication skills, analytical skills, interpersonal skills, teamwork and decision-making skills are required.
Strong organization skills and attention to detail, along with the ability to prioritize multiple tasks and plan proactively to achieve goals with tight timelines is required.
Able to work independently with a high level of logistical planning.
Membership in ACT/SOT encouraged.
The salary range for this position is: $143,225.00 - $185,350.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. 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:
Gilead Benefits .
#J-18808-Ljbffr