Senior Scientist – Pharmacyclics, LLC – Sunnyvale, CA

Job ID: 5986
Job date: 2016-09-17

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Job Description:
Specific Responsibilities

We are seeking experienced Senior Biomarker Scientist to support our therapeutic areas of interest including solid tumors, immunooncology and hematological malignancies, e.g., CLL, DLBCL, FL, MZL, WM, MM, AML. The Senior Biomarker Scientist 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 Science. 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. Direct experience in development, outsourcing and validation of clinically applicable biomarker assays is required. A strong applicant will also have broad experience with the application to biomarker programs, including but not limited to, ELISA, flow cytometry, gene expression microarrays, qPCR, comparative genomic hybridization, RNAseq, Nanostring, NGS, mass spectrometry, and/or protein arrays.

Essential Duties and Job Functions
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. Design, implement and oversee biomarker and diagnostic assay development, testing and data analysis. Oversee BM assay outsourcing. Collaborate with biostatistics and bioinformatics colleagues to design data analysis plans. Interpret and communicate BM and Dx results for informed decision-making. Hands on experience for biomarker data analysis, specifically for microarray data and targeted proteomics for biomarker identification Author biomarker and diagnostic related sections of clinical study protocols and biomarker reports. Provide input to clinical study reports, statistical analysis plans, biomarker analysis plan and laboratory manuals. Support drug and/or companion Dx filing and registration activities, including interpretation and preparation of biomarker results and documents needed for filing purposes, and participation in meetings with regulatory agencies as needed. Utilize BM approaches to investigate the mechanism of action of therapeutics in development to generate insights that can be leveraged in drug discovery and novel target identification. Present to and participate in Advisory Boards and key opinion leaders (KOL) meetings as needed. Knowledge, Experience and Skills
5+ years of experience with PhD or MD/PhD in related scientific discipline including 2 or more years’ experience in clinical biomarker field Direct experience in human translational research with biomarker application in clinical trials Direct experience in biomarker data analysis, specifically for microarray data and targeted proteomics for biomarker identification Proven successful research in industrial or academic settings Ability to independently lead and conduct research, and to evaluate, interpret and present complex scientific data with minimal supervision. Ability to interact productively with external investigators and corporate partners. Excellent verbal and written communication and presentation skills


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