Gilead Sciences, Inc.
Sr Scientist, Biomarker - Oncology
Gilead Sciences, Inc., Foster City, California, United States, 94420
We are seeking an experienced Senior Research Scientist to support Gilead’s Oncology pipeline. This role requires strong experimental background and experience in hypothesis-driven biological/translational research with demonstrated ability to execute well-designed experiments in immunology and/or oncology. The scientist will need to be able to provide scientific leadership and disease biology direction with a focus on tumor biology but highly integrated with immunology/immuno-oncology, through the creation and execution of high-quality integrated discovery and translational plans to support early programs at preclinical and clinical stages. Strong scientific communication and interactions with external collaborators and with key opinion leaders, academic sites will be critical to advancing their programs, translational objectives and disease area strategies. To this end, experience in the analysis early and late stage clinical trials with multi-dimensional human data sets including with genomic, epigenetic, gene expression, metabolomics, multiplexed protein detection or other related emerging platforms or data sets is desirable.
In addition to the primary translational efforts, the successful candidate 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 efforts for late-stage or early development programs. This will involve the designing of biomarker experiments and providing biomarker expertise to discovery and development project teams to ensure access to state-of-the-art thinking on appropriate biomarker and diagnostic technologies. 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 implementation of clinically applicable biomarker assays (including pharmacodynamic, predictive, prognostic, and other biomarkers) and oversee biomarker testing and data analysis together with the specific functional area representatives, including partnering with the diagnostic team, Clinical Development and Research partners. 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.
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
Designing and implementing translational research plans which includes leveraging clinical samples, partnering with external and internal leaders, multi-omic profiling, spatial biology, and functional assays to uncover mechanisms of response, resistance, and disease evolution
Must be team and detail-oriented, motivated, and results focused
Basic Qualifications
High School Degree and Twelve Year's Experience
Associates Degree and Ten Years Experience
Bachelor's Degree and Eight Years’ Experience
Masters' Degree and Six Years’ Experience
Ph.D.
Preferred Qualifications
PhD and/or post-doctoral training in the area of immunology and/ or oncology or other related medical science field with a minimum of 5 years of directly relevant biotechnology or pharmaceutical industry experience (7+ years experience preferred)
Candidate must be detail-oriented with excellent record keeping and organizational skills
Must be a highly flexible, results oriented, independent self-starter who enjoys working in a fast paced dynamic multi-disciplinary environment
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
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
Experience with analyzing high-content NGS data and other human datasets to define therapeutic mechanisms of action and resistance and patient enrichment strategies
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)
Results-oriented, independent self-starter who thrives working in a fast-paced dynamic environment
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
People Leader Accountabilities
Create Inclusion – knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams
Develop Talent – understand the skills, experience, aspirations, and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop, and realize their purpose
Empower Teams – connect the team to the organization by aligning goals, purpose, and organizational objectives and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem
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In addition to the primary translational efforts, the successful candidate 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 efforts for late-stage or early development programs. This will involve the designing of biomarker experiments and providing biomarker expertise to discovery and development project teams to ensure access to state-of-the-art thinking on appropriate biomarker and diagnostic technologies. 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 implementation of clinically applicable biomarker assays (including pharmacodynamic, predictive, prognostic, and other biomarkers) and oversee biomarker testing and data analysis together with the specific functional area representatives, including partnering with the diagnostic team, Clinical Development and Research partners. 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.
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
Designing and implementing translational research plans which includes leveraging clinical samples, partnering with external and internal leaders, multi-omic profiling, spatial biology, and functional assays to uncover mechanisms of response, resistance, and disease evolution
Must be team and detail-oriented, motivated, and results focused
Basic Qualifications
High School Degree and Twelve Year's Experience
Associates Degree and Ten Years Experience
Bachelor's Degree and Eight Years’ Experience
Masters' Degree and Six Years’ Experience
Ph.D.
Preferred Qualifications
PhD and/or post-doctoral training in the area of immunology and/ or oncology or other related medical science field with a minimum of 5 years of directly relevant biotechnology or pharmaceutical industry experience (7+ years experience preferred)
Candidate must be detail-oriented with excellent record keeping and organizational skills
Must be a highly flexible, results oriented, independent self-starter who enjoys working in a fast paced dynamic multi-disciplinary environment
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
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
Experience with analyzing high-content NGS data and other human datasets to define therapeutic mechanisms of action and resistance and patient enrichment strategies
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)
Results-oriented, independent self-starter who thrives working in a fast-paced dynamic environment
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
People Leader Accountabilities
Create Inclusion – knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams
Develop Talent – understand the skills, experience, aspirations, and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop, and realize their purpose
Empower Teams – connect the team to the organization by aligning goals, purpose, and organizational objectives and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem
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