Research Scientist Ii

Description:

The Biomarker Sciences Department is seeking an experienced Senior Research Scientist II to support Gilead's Oncology pipeline. The successful candidate will will work in a dynamic multidisciplinary matrixed team environment to generate and interpret data from translational and clinical studies, and be expected to lead and support biomarker subteams for late-stage or early development programs. This scientist will design biomarker experiments and provide biomarker expertise to discovery and development project teams to ensure access to state of the art thinking on appropriate biomarker and diagnostic technologies, including evaluation of their scientific basis and clinical applicability, the validation status and any technical or statistical issues related to the proposed biomarker assays. The scientist will provide input on clinical protocols and associated documents as well as participate in meetings with regulatory authorities. In addition, the scientist will direct the development, outsourcing and validation of clinically applicable biomarker assays (including pharmacodynamic, predictive, prognostic, and other biomarkers) and design, implement and oversee biomarker testing and data analysis together with the specific functional area representatives, including partnering with the diagnostic team. 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 in the analysis of multi-dimensional data sets and a strong understanding of mechanisms of immunology and a background in cancer cell signaling research and translational biology is highly desirable.

Responsibilities:

Lead cross-functional Biomarker Teams to define and execute biomarker/diagnostic development strategies 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 external collaborations with key opinion leaders, academic sites, and CROs to advance our understanding of disease pathways and prognostic/predictive biomarkers
Collaborate with Research Biology, Clinical Development, Diagnostics, Bioinformatics and Biostatistics functions to create synergy in developing biomarker strategies and translational approaches
Write, review and coordinate biomarker plans in clinical trial protocols, regulatory documents and collaboration agreements.
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, with the ability to effectively organize and present plans and results at department, company, and/or project team meetings.
Must be team and detail-oriented, motivated, and results focused.

Technical Skills:

Strong experimental background and experience in hypothesis-driven biological/translational research with demonstrated ability to execute well-designed experiments in tumor immunology
Experience planning and executing biomarker and diagnostic strategy, experimentation and testing in support of drug discovery and development, including analysis and interpretation of biomarker data in preclinical and clinical setting
Experience authoring biomarker strategy documents, biomarker specific portions of clinical protocols and regulatory documentation. 
Experience in the analysis of multi-dimensional data sets including with genomic, epigenetic, gene expression, metabolomics, multiplexed protein detection or other related emerging platforms or data sets is desirable.
Demonstrates technical proficiency, scientific creativity, collaboration with others and independent thought in suggesting biomarker and diagnostic strategies for immunology and/or oncology clinical development
Understands the multidisciplinary functions involved in biomarker and diagnostics development.
In-depth knowledge of biomarker discovery and development, assay development / validation, clinical discovery of biomarkers, MoA / translational research and companion diagnostics development.
Understands the opportunities and challenges in implementing biomarker and diagnostic technologies in a preclinical and clinical setting, including understanding of drug discovery and development in both early and late-stage development and familiarity with the regulatory approval process.
Proven track record in effectively applying original scientific thought to the development of project concepts or approaches for experimentation.
Proven scientific/leadership expertise (working in teams, managing people/projects commensurate with level)
Proven abilities to apply business acumen to strategic scientific projects.
Results-oriented, independent self-starter who thrives working in a fast-paced dynamic environment.
Demonstrated success in managing multiple projects.
Has a strong track record of high-quality publications.
Strong communication and organizational skills, with an ability to lead, influence, and motivate others.
When needed, ability to travel.