Sr. Director, Biomarker - Inflammation
Sr. Director, Biomarker - Inflammation
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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Sr. Director, Inflammation, Biomarker Sciences
Gilead is seeking a biomarker expert to head their Inflammation/Immunology Group. We are seeking an experienced, exceptional scientist who will work in a dynamic, multidisciplinary matrixed team environment to generate and interpret data from translational and clinical studies.
The candidate will work closely with the Research Biology and Therapeutic leadership teams to develop and support the strategic direction in the field of inflammation focused on the development of therapies for rheumatic diseases and inflammatory bowel disease. The incumbent is responsible for 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).
Biomarker Sciences at Gilead Sciences
The Biomarker Sciences Department is part of Gilead's Development organization, and leads early and late stage clinical biomarker research and development activities for the pipeline and supports the late stage portfolio for regulatory, translational development, diagnostic partnering and life cycle management.
Essential Duties and Job Functions
- Provides expert guidance to multi-disciplinary teams and senior management.
- 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.
- 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.
- This position will report to the Head of the Inflammation/Fibrosis Therapy Area and be a member of the Biomarker Sciences Leadership team and relevant Development cross-functional leadership teams.
- Lead a group of biomarker scientists responsible for multiple programs and oversee biomarker strategy development and implementation of the inflammation aspects of Gilead's program ensuring effective utilization of biomarker approaches to address key program questions
- 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 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.
- 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, Development (Clinical Research), Clinical Pharmacology, Data Science (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 inflammation.
- Experience with genomic, epigenetic, gene expression, metabolomics, multiplexed protein detection or other related emerging platforms or data sets is desirable.
- 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 immunology or related field
- Ability to integrate complex scientific ideas, generate testable hypotheses, and execute
- Analysis and interpretation of biomarker data in preclinical and clinical setting
- Experience with multi-dimensional data analysis is beneficial
- Broad understanding of drug discovery and development in both early and late stage
development and familiarity with regulatory approval process.
- 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
- Basic understanding of technical aspects of companion diagnostics development
- Proven scientific/leadership expertise (working in teams, managing people/projects commensurate with a senior level)
- Proven publication record
- Strong verbal and written communication skills
- Understanding of IP, contracting terms and provisions
- PhD and/or post-doc training in the area of inflammatory autoimmune diseases, immunology, or other related medical science field with a minimum of 15 years of 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 and 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 firstname.lastname@example.org for assistance.
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