Gilead Sciences is continuing to hire for all open roles. Our interview process may be conducted
virtually and some roles will be asked to temporarily work from home. Over the coming weeks and
months, we will be implementing a phased approach to bringing employees back to site to ensure
the health and safety of our teams.
Please log onto your Internal Career Site to apply for this job.Job Description
The Biomarker Sciences Department is seeking an experienced and exceptional Scientist at Director level in the Immuno-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 CDx strategies for programs in both solid tumors and hematological malignancies. 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 (including pharmacodynamic, predictive, prognostic, and other biomarkers) and 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 in successful developing and executing biomarker and CDx strategy in clinical stage programs in immuno-Oncology field and a strong understanding of clinical development in solid tumors are highly desired.
- Lead cross-functional Biomarker Teams to develop and execute biomarker/diagnostic 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 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 Research, Bioinformatics and Biostatistics functions 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.
- Demonstrated expertise in immunolog and/ or 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 and familiarity with regulatory approval process.
- Experience with the discovery, characterization, clinical validation and utilization of innovative biomarkers and potential diagnostics.
- 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
- Broad experience in technical aspects of companion diagnostics development
- 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
PhD and/or post-doctoral training in the area of immunology and/ or oncologyor other related medical science field with a minimum of 10 years of directly relevant biotechnology or pharmaceutical industry experience. 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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Please log onto your Internal Career Site to apply for this job.