Senior Manager, Inflammation, Fibrosis Biomarkers

Gilead Sciences


July 31, 2014

Specific Responsibilities:

The Senior Manager, Biomarkers will facilitate lead the development and execution of specific elements of the biomarker and diagnostic strategy for research and development projects. He/she will design, implement and oversee biomarker and diagnostic testing and data analysis for clinical studies. The Senior Manager will also evaluate the clinical applicability, validation status and any scientific, technical or statistical issues related to biomarker assay implementation. He/she will be a point of contact providing help and expert scientific advice related to biomarker sample collection, storage and sample and data analysis to other functions (e.g. Contracts, Clinical Operations, Data Management, etc.) to facilitate their interactions with internal and external laboratories.

Essential Duties and Job Functions:

• Responsible for design, implementation and oversight of biomarker and diagnostic testing in clinical studies and biomarker data analysis
• Manages the development and validation of clinically applicable biomarker assays with external service laboratories
• Prepares and reviews biomarker sections of clinical protocols, ICFs, lab manuals, and clinical study reports
• Coordinates and monitors biomarker sample collection, handling and analysis in clinical studies
• Collaborates with biostatistics and bioinformatics to design data analysis plans
• May be required to participate hands-on in the lab to facilitate and assist with biomarker assay development and/or validation
• May help design or support research biomarker strategy and assay development

Knowledge, Experience and Skills:

• PhD in Cell Biology, Immunology or Molecular Biology or related field and a minimum of 5 years research experience in a pharmaceutical or biotech environment. Must have biomarker expertise in one or more of the following therapeutic areas: Fibrosis, immunology, or inflammation
• Experience with the discovery, characterization, clinical validation and utilization of innovative biomarkers and potential diagnostics
• Experience in development, outsourcing and validation of clinically applicable biomarker assays
• Direct laboratory experience with ELISA, multi-color flow cytometry, and human tissue specimens is required
• A strong applicant will also have experience with gene expression microarrays, qPCR, comparative genomic hybridization, and protein arrays
• Excellent verbal communication and interpersonal skills are required
• Must be able to multi-task and work effectively within a team environment
• Managerial experience a plus but not required
• Strong motivation, attention to detail, ability to think independently and fully integrate into a high achieving team environment

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