The Director, Biomarker Sciences is responsible for the design of biomarker and diagnostic strategies for Gilead HIV virology programs. The individual will direct the development, outsourcing and validation of clinically applicable biomarker assays (including pharmacodynamic, predictive, prognostic, safety and other biomarkers). Duties also include the implementation and oversight of biomarker and diagnostic testing and data analysis. The successful candidate will work in a dynamic multidisciplinary matrixed team environment to support both early and late stage clinical programs. This will include input on clinical protocols and associated documents as well as participation in meetings with regulatory authorities. 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 development and execution of biomarker strategies for clinical stage programs and a strong understanding of clinical development for virology programs is highly desired.
Lead development of project specific biomarker and diagnostic strategies for HIV Virology Cure Program(s).
Lead a cross-functional Biomarker Team to oversee the delivery of biomarker and diagnostic strategies.
Identify, establish and oversee external collaborations with key opinion leaders/CROs to advance understanding of host viral responses.
Provide expertise to research and development teams to ensure access to state of the art thinking on immune assay technologies, evaluating their scientific basis and clinical applicability.
Collaborate with expertise in Research Biology for synergy in interrogating both viral and immune-related mechanisms.
Strong experimental background with demonstrated ability to execute well-designed decision-making experiments
Maintain knowledge of scientific advances and competitive activity from literature, scientific meetings and external contacts.
Must be able to work independently and effectively on multiple programs in a fast paced environment.
Excellent communication and interpersonal skills are required.
Strong motivation, attention to detail and full integration into a high achieving team environment.
High level of business awareness.
Some management of direct reports will be required.
Demonstrated expertise in immunology and/or virology.
Broad understanding of drug discovery and development in both early and late stage
development and familiarity with the regulatory approval process.
Strong background in technologies associated with immune drug development programs such as immunoassays, FACS, CyTOF, IHC/IF, single cell analysis and nucleic acid sequencing and analysis.
Knowledge of biomarker discovery and development: assay development/validation, clinical discovery of biomarkers, mechanism of action studies.
Authoring of biomarker strategy documents and biomarker specific portions of clinical protocols.
Basic understanding of technical aspects of companion diagnostics development.
Analysis of preclinical and clinical biomarker data.
Proven publication record.
Strong verbal and written communication skills.
Basic understanding of intellectual property, contracting terms, and provisions.
PhD and/or post-doctoral training in immunology, virology or similar with a minimum of 10 years of directly relevant biotechnology or pharmaceutical industry experience. Direct experience with HIV a plus.
Knowledge of bioinformatics and experience in statistics and programming languages is a plus. 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