Director, Biomarker - Oncology
Director, 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. Gileads therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
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Inclusion is one of the companys five core values. Thats because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.
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Director, Oncology, Biomarker Sciences
The Biomarker Sciences Department is seeking an experienced and exceptional Scientist at Director level to support 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 CDx strategies for 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 (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 Oncology and a strong understanding of clinical development in solid tumors are required.
- 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 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 portions 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.
Previous people management 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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As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans\' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact email@example.com for assistance.
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