Sr. Research Scientist II - Biomarker - Oncology

Sr. Research Scientist II - Biomarker - Oncology
United States - California - Foster City

Gilead Sciences, Inc. is a research-based bio-pharmaceutical company 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, and serious respiratory and cardiovascular conditions.

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Job Description
Job Description:

Senior Research Scientist II, Oncology, Biomarker Sciences

The Biomarker Sciences Department is seeking an experienced and exceptional Senior research scientist in the Oncology therapeutic area. The successful candidate will work in a dynamic multidisciplinary matrixed team environment to support both early and late stage clinical programs. He/she will be responsible for the development and execution of biomarker and translational strategies for clinical programs in solid tumors. The scientist will provide expertise to discovery and development project teams to ensure access to state of the art thinking on appropriate biomarker and diagnostic technologies, evaluate their scientific basis and clinical applicability, the validation status and any technical or statistical issues related to the proposed biomarker and/or diagnostic assays. This will include input on clinical protocols and associated documents as well as participation in meetings with regulatory authorities. In addition, the scientist will direct the development, outsourcing and validation of clinically applicable biomarker assays, design, implement and oversee biomarker and diagnostic testing and data analysis together with the functional area representatives. The successful candidate will lead cross functional teams to achieve these aims. Gilead Sciences Inc. is a highly matrixed organization and the ability to work effectively across these groups is a key attribute for this role. Experience and proven track record in successful developing and executing biomarker strategy in clinical stage programs in Oncology field and a strong understanding of clinical development in solid tumors are highly desired.

Responsibilities:

• Lead cross-functional Biomarker and Translational Teams to develop and execute biomarker strategies and to generate, analyze, and interpret data from clinical studies
• Direct the development, outsourcing, and validation of clinically applicable biomarker assays including pharmacodynamic, predictive, prognostic, safety and other biomarkers for oncology programs
• Identify, establish and oversee collaborations with academic sites, and CROs to advance our understanding of disease pathways and prognostic/predictive biomarkers
• Collaborate with Research Biology, Clinical Research, Bioinformatics and Biostatistics functions within Gilead to create synergy in developing biomarker strategies and translational approaches
• Strong experimental background and experience in hypothesis-driven biological/translational research with demonstrated ability to execute well-designed experiments in tumor immunology
• Must be able to work independently and effectively on multiple programs in a fast-paced matrixed environment
• Excellent collaboration, communication, and interpersonal skills are required to engage and be productive within a high achieving team environment
• Must be team and detail-oriented, motivated, and results focused.

Technical Skills:

• Demonstrated expertise in oncology clinical development
• Ability to integrate complex scientific ideas, generate testable hypotheses, and execute
• Analysis and interpretation of biomarker data in preclinical and clinical setting
• Broad understanding of drug discovery and development in both early and late stage
  development.
• Knowledge of biomarker discovery and development, assay development/validation, clinical discovery of biomarkers, and MoA/translational research.
• Authoring of biomarker strategy documents, biomarker specific portion of clinical protocols, and regulatory documents
• Proven scientific/leadership expertise (working in teams, managing people/projects commensurate with level)
• Proven publication record
• Strong verbal and written communication skills
• Understanding of IP, contracting terms and provisions

Experience:

* PhD and/or post-doctoral training in the area of oncology/drug development with minimum 5 years, preferably 7 years, of biomarkers development experience, in relevant biotechnology or pharmaceutical industry.

* Candidate must be detail-oriented with excellent organizational skills.

Must be a highly flexible, results oriented, independent self-starter who enjoys working in a fast paced dynamic multi-disciplinary environment.


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