VP, NonClinical Safety and Pathobiology
Gilead Sciences
- Location
- United States - California - Foster City
- Work model
- On-Site
- Level
- Staff
- H-1B history
- 75 approvals (FY2023)
- Posted
- 22h ago
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
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.
Key Responsibilities
Nonclinical Safety and Pathobiology (NSP) group is responsible for design, implementation, oversight and analysis of nonclinical programs to support drug development candidates from research to registration. NSP group is comprised of Toxicology, Pathology, and Environmental / Occupational Toxicology. NSP is responsible for ensuring patient safety of Gilead drug candidates through exhaustive non-clinical evaluations. NSP is responsible for ensuring global compliance with worldwide regulations governing the conduct of Gilead’s nonclinical studies in support of global clinical trials, registration, and new drug approvals. NSP is responsible for Pathobiology characterization of animal models and clinical specimens as needed to advance translational understanding of new targets and new therapeutics. Manages and mentors a group of Ph.D. level toxicologists and pathologists to ensure NSP continues to develop and implement cutting edge scientific technologies and drug development strategies. Prepares and reviews regulatory documents including INDs/IMPDs, Investigator Brochures and NDAs/MAAs. Communicates successfully cross-functionally to accomplish Company goals. Solves highly complex problems requiring evaluation of business intangibles in addition to thorough scientific assessment. Knowledge: Experience in successful conduct of nonclinical programs as well as preparation, submission and approval of nonclinical sections of regulatory filings covering all stages of development. Has an in-depth knowledge of nonclinical drug discovery and development and regulatory environments in the US, EU and