Director, Nonclinical Safety

Gilead Sciences•Foster City, CA

About The Position

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, cancer 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. Job Description We are seeking a bright and enthusiastic Director ofto complement our Nonclinical Safety group. 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. The primary responsibility is to serve as the toxicology representative on multifunctional project teams, including ownership of the nonclinical safety program and contributing to regulatory documents to support drug development candidates across a variety of platforms from early research through registration/post approval. Serves as a nonclinical safety development resource, working with other members of the department regarding strategy for nonclinical safety programs. Plays key role on cross functional teams – both Research and Development Project Teams where he/she is responsible for design, implementation, oversight and analysis of nonclinical programs to support drug development candidates across a variety of platforms. Writes and reviews regulatory documents to support global regulatory filings. Manages multiple projects simultaneously with minimal supervision. Reviews protocols, data and study reports ensuring presentation of data in report is accurate and supports the conclusions. Interprets and puts data into context with literature and project goals. Provides independent technical contributions. Actively supports the integration of early nonclinical safety strategies throughout Research. Lead Non-Clinical Development sub-teams. Solves complex problems requiring thorough scientific assessment. Models behaviors that nurture a culture of innovation. Participate in and lead significant process improvement initiatives that may impact the department. Communicates effectively cross-functionally to accomplish company goals. Be a team player who thrives in a high speed environment where autonomy, accountability and innovation are critical for success.

Requirements

12+ years of experience with PhD in related scientific discipline.
BS or MS degree with extensive industry experience.

Nice To Haves

Experience with use of NAM's and AI ( pertaining to nonclinical toxicology) highly desirable

Responsibilities

Serve as the toxicology representative on multifunctional project teams, including ownership of the nonclinical safety program and contributing to regulatory documents to support drug development candidates across a variety of platforms from early research through registration/post approval.
Serve as a nonclinical safety development resource, working with other members of the department regarding strategy for nonclinical safety programs.
Play key role on cross functional teams – both Research and Development Project Teams where he/she is responsible for design, implementation, oversight and analysis of nonclinical programs to support drug development candidates across a variety of platforms.
Write and review regulatory documents to support global regulatory filings.
Manage multiple projects simultaneously with minimal supervision.
Review protocols, data and study reports ensuring presentation of data in report is accurate and supports the conclusions.
Interpret and put data into context with literature and project goals.
Provide independent technical contributions.
Actively support the integration of early nonclinical safety strategies throughout Research.
Lead Non-Clinical Development sub-teams.
Solve complex problems requiring thorough scientific assessment.
Model behaviors that nurture a culture of innovation.
Participate in and lead significant process improvement initiatives that may impact the department.
Communicate effectively cross-functionally to accomplish company goals.
Be a team player who thrives in a high speed environment where autonomy, accountability and innovation are critical for success.

Benefits

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.

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