Sr Associate Scientist, Nonclinical Safety

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

With increasing independence monitors and coordinates all aspects of non-GLP and GLP outsourced nonclinical safety studies (e.g., 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

Specific

Job Responsibilities:



• Coordinates all aspects of initiating and conducting a non-clinical study, with minimal supervision.

• Drafts and coordinates review of relevant documents including protocols and study reports.

• Coordinates review of data and preparation of interim and final study reports.

• Assists in the preparation of non-clinical regulatory documents including QC of data.

• Independently manages study resources and timing

• With guidance, designs dose selection or study result presentations

• With guidance, contributes to tabulated sections of regulatory documents

Basic Qualifications:

BA/BS with 5 years of experience

OR

MA/MS with 3 years of experience

Preferred Qualifications:

Multiple years’ nonclinical study monitoring experience. Direct experience with leading larger moderately-complex non-GLP and GLP-regulated studies

Pharmaceutical or CRO industry experience in small molecule and/or biopharmaceutical drug development

Strong attention to detail, including the ability to prioritize multiple tasks and plan proactively to achieve goals with tight timelines

Able to work independently with a high level of logistical planning

Knowledge of the general principles and methods of toxicology, animal and human biology and physiology

Knowledge of laboratory animal welfare standards (USDA, AALAC, etc.) and familiar with IACUC review

Demonstrates increased knowledge of FDA, OECD, ICH guidelines, and GLPs governing the conduct of nonclinical studies by ensuring applicable guidelines are appropriately applied to study protocols and reports

Has thorough knowledge of nonclincal study management, from prestudy activities through closeout, and applies this knowledge to achieve study and project objectives

Fully understands protocol and reporting requirements and effectively interprets data from studies for accuracy

Basic understanding of CRO contracting and financial aspects of study management

Able to prioritize and complete large volumes of work

Coordinates all aspects of initiating and conducting a non-clinical study, with minimal supervision.

Drafts and coordinates review of relevant documents including protocols and study reports.

Coordinates review of data and preparation of interim and final study reports.

Assists in the preparation of non-clinical regulatory documents including QC of data.

Travel is required

Job Description

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…