Sr Director, Project Toxicologist

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, Oncology 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.

We are seeking a bright and enthusiastic senior toxicologist to complement our Nonclinical Safety (i.e. Toxicology) 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.

Key Aspects:

The Sr. Project Toxicologist works in a project team-based research structure to lead and collaborate with new and ongoing projects.

• 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.

Knowledge:

• Strong knowledge and scientific expertise in subject area/discipline; familiar with other disciplines inside and/or outside of department

• Knowledge of nonclinical requirements to support research projects.

• Knowledge and understanding of GLPs.

• Knowledgeable of regulatory requirements, including ICH requirements and other regional requirements.

• Is sought out for advice by others within the department and related functional areas.

Education and Experience:

• PhD in Toxicology or a related scientific discipline with 15+ years of biopharmaceutical, regulatory, or CRO industry experience.

• Experience with both small molecule modalities and biologics.

• Board certification is desirable.

• Demonstrable innovative, flexible and critical thinking skills and experience applied to hypothesis-driven nonclinical safety research.

• Strong motivation, independence, and the ability to work in a fast-paced, multidisciplinary, matrix environment with minimal supervision.