Gilead is seeking a biomarker expert to head their Inflammation/Immunology Group.
The candidate will work closely with the Research and Therapeutic leadership teams to develop and support the strategic direction in the broad inflammation/immunology arena. The incumbent is responsible for building and leading of a group focused on developing and delivering on a clinical biomarker strategy to evaluate target engagement, pharmacodynamic assessments to inform dose selection, elucidate drug mechanisms of action, potential combination strategies, patient stratification and/or selection and to investigate mechanisms of resistance (innate and acquired).
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The Biomarker Group is part of Gilead’s Research organization, and leads early and late stage clinical biomarker research and development activities for the pipeline and supports late stage portfolio for regulatory, translational development, diagnostic partnering and life cycle management.
Summary:
This role reports to the Vice President, Biomarkers.
Key responsibilities of this role are:
• Lead a group of biomarker scientists responsible for multiple programs and oversee biomarker strategy development and implementation of the inflammation/immunology aspects of Gilead’s program
• Work closely with the Biomarker Sciences leadership team to ensure alignment and synergies are captured across therapeutic areas
• Act as the translational representative on Project teams to advance the Gilead portfolio in inflammatory (and fibrotic) diseases.
• Use biomarkers to identify opportunities to study Gilead compounds in new indications/combinations.
• Use biomarkers in developing an approach for immunologic safety monitoring and assessment.
Technical Skills:
• Demonstrated expertise inflammatory diseases, immunological and potential fibrotic mechanisms.
• Broad understanding of drug discovery and development especially late stage development and approval process.
• Knowledge of biomarker discovery and development: assay development/validation, clinical discovery of biomarkers, MoA research, knowledge of platforms.
• Authoring of biomarker portion of clinical protocols, drug study reports, regulatory submissions.
• Analysis of biomarker data in preclinical and clinical setting.
• Basic understanding of technical aspects of companion diagnostics development; partnerships, due diligence experience, project experience (Pre-Submission and IDE development; Diagnostic protocol etc.).
• Proven scientific/leadership expertise (working in teams, managing people/projects).
• Proven publication record.
• Strong verbal and written communication skills.
• Ability to synthesize complex scientific and business problems into strategy and tactics.
• Basic understanding of IP, contracting terms and provisions.
Essential Duties and Job Functions
• Responsible for the development of the biomarker section of Gilead clinical protocols in trials and represents biomarker strategy at key review meetings and plans execution.
• Leads the analysis of biomarkers for Gilead clinical studies by working with key internal stakeholders and external CROs as needed to generate biomarker study reports.
• Develops and mentors Biomarker leads
• Provides expert guidance to multi-disciplinary teams and senior management.
Knowledge, Experience and Skills
PhD in life sciences or medical sciences, and a minimum of 12+ years of directly relevant biotechnology or pharmaceutical industry experience. 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 environment.
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