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Director, Nonclinical Safety

United States - California - Foster CityClinical Development & Clinical OperationsRegular
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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 to 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.

Key Requirements

  • Specific Education & Experience Requirements:
  • 12+ years of experience with PhD in related scientific discipline.
  • Experience with use of NAM's and AI ( pertaining to nonclinical toxicology) highly desirable
  • BS or MS degree with extensive industry experience.
  • Specific Job Responsibilities: