Associate Director, Biomarker Sciences
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POST DATE 8/18/2016
END DATE 10/18/2016
Gilead Sciences, Inc
Foster City, CA
JOB DESCRIPTIONSPECIFIC RESPONSIBILITIES
We are expanding the Biomarker Sciences department and are seeking experienced scientists to support our therapeutic areas of interest oncology, inflammation, respiratory, and liver disease. The Associate Director will be responsible for the development and implementation of biomarker and diagnostic strategies to enable and support the discovery, development and commercialization of medically-differentiated therapies primarily in one of our therapeutic areas of interest. This person will lead the development and implementation of biomarker and diagnostic strategies for individual projects through interfacing with Research Biology and Clinical Research. He/she 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, he/she will direct the development, outsourcing and validation of clinically applicable biomarker assays (including pharmacodynamic, predictive, prognostic, safety and other biomarkers) and design, implement and oversee biomarker and diagnostic testing and data analysis together with the specific functional area representatives. The Associate Director will lead cross functional teams to achieve these aims. Gilead is a highly matrixed organization and the ability to work effectively across these groups is a key attribute for this role.
Must have expertise in one or more of the following therapeutic areas: oncology, hematology, immunology, inflammation and/or liver disease.
* - Lead biomarker and diagnostic strategy development and execution for individual research and development projects
* - Provide expertise to research and development teams to ensure access to state of the art thinking on appropriate biomarker and diagnostic technologies, evaluating their scientific basis and clinical applicability, the validation status and any technical or statistical issues related to the proposed biomarkers and/or diagnostics:
* - Provide input on biomarker and diagnostic related sections of clinical study protocols, clinical study reports, statistical analysis plans, laboratory manuals, etc.
* - Experience investigating mode of action, resistance, combination of targeted therapeutics agents in complex biological systems including patient samples and/or animal models
* - Experience in application of a broad array of biomarker technologies in clinical trials and awareness of the challenges of implementing technologies in the clinical setting
* - Identifying, defining and overseeing external collaborations with key opinion leaders/CROs which support projects in diverse therapeutic areas
* - Strong experimental skills 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
* - Experience in generation of non-clinical sections of Regulatory documents an advantage
* - Excellent verbal communication and interpersonal skills are required.
* -Strong motivation, attention to detail, and ability to think independently and fully integrate into a high achieving team environment
* -High level of business awareness
ESSENTIAL DUTIES AND JOB FUNCTIONS
Lead cross-functional Biomarker Teams to develop and oversee the delivery of biomarker and diagnostic strategies across one or multiple therapeutic areas:
- Communicate the value of the biomarker and diagnostic efforts within Gilead and provide expert BM and Dx input to the leadership team to inform strategy and portfolio decisions
- Integrate knowledge of signaling pathway biology with molecular characteristics of patient subpopulations (histology, molecular subtype, etc) to enable an integrated biomarker strategy
- Lead efforts focused on molecular characterization of clinically relevant samples with respect to therapeutically related biomarkers for drug candidates in research and development
Provide expertise to research and development teams to ensure access to state of the art thinking on appropriate biomarker and diagnostic technologies, evaluating their scientific basis and clinical applicability, the validation status and any technical or statistical issues related to the proposed biomarkers and/or diagnostics:
- Provide input on biomarker and diagnostic related sections of clinical study protocols, clinical study reports, statistical analysis plans, laboratory manuals, etc.
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