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Global Biomarker Monitor and Study Coordinator

Company name
Translational Medicine

Location
Cambridge, MA

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Job Description The Novartis Institutes for BioMedical Research (NIBR) is the innovation engine of Novartis, focusing on powerful new technologies that have the potential to help produce therapeutic breakthroughs for patients. NIBR includes about 6500 associates across 7 locations worldwide. Translational Medicine (TM) is the clinical research arm of NIBR, and includes about 1000 associates globally. TM plays a pivotal role in bringing innovative medicines to patients, by building on research advances to develop new therapies, and bridging drug discovery and clinical application. The Biomarker Development Department works in partnership with Novartis and external translational biologists, physicians and companies to develop precision medicines for all stages of clinical development by applying state of the art imaging, proteomic, genetic, genomic, cellular and computational approaches which address clinical and biological pathway questions. Global Biomarker Monitor and Study Coordinator is a key global resource for BMD Line functions and NIBR TM Clinical Trial Teams for clinical biomarkers including leading biomarker outsourcing, scientific biomarker monitoring, strategic vendor management, study coordination and clinical sample management across TM study portfolio Novartis Institutes for BioMedical Research (NIBR) is the global pharmaceuti-cal research organization committed to discovering innovative medicines that treat disease and improve human health. Laboratory Excellence and Opera-tion team lead and provide support for clinical biomarkers and assay outsourcing, global vendor management, scientific biomarker monitoring, sample management and operational planning\/coordination to other internal NIBR Novartis functions, such as Biomarker Development and Translational Medicine The successful candidate will: 1.Lead global clinical assay and biomarker outsourcing in multiple biomarker modalities (e.g. Immunoassay, LC-MS, Flow cytometry, etc.) including assay oversight, scientific data monitoring, data transfers, data flows and scientific results interpretations and ensure quality and timely deliverables 2.Serve as the subject matter expert in outsourcing of clinical biomarkers (e.g. Immunoassay, mass spectrometry, etc.) in support of global and Asia clinical studies. Independently identify, and resolve complex biomarker and assay troubleshooting issues, sample management, ESP, quality or performance issues and engage LF experts, clinical trial leaders and data management as needed 3.Support TM global clinical studies and contribute to clinical teams including clinical study protocol, site operations manuals, informed consent forms, sample collection tables, instruction manual, central lab protocol\/manual and other biomarker study setups 4.Lead strategic and global (US, EU and Asia) vendor management includ-ing vendor benchmarking, partnership with NBS, partnership with LFs (e.g. TM, PKS and PCS) and negotiations with global external service providers (ESP) to ensure global and strategic alignment 5.Lead root cause analysis and device creative and novel system solutions. Collaborate with internal NVS functions, clinical teams, sites, and ESPs to develop global best practices and continuous improvement initiatives and innovations 6.Mentor and develop junior lab heads and PIs in US 7.Serve as Biomarker Expert (BME) in global TM clinical studies and con-tribute to the biomarker strategy and clinical study designs The position will be located in Cambridge US. EEO Statement The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status. Minimum requirements Minimum: PhD degree with 6 years in clinical operations and clinical as-says \/bioanalysis Desirable: project management, training\/experiences in global clinical study operation, GxP regulatory compliances, vendor management and\/or laboratory experience Experience \/ Professional Requirement: 1.Strong scientific knowledge of global clinical operations, clinical sample and biomarker analysis. Track record of independent contributions to global clinical studies, clinical assay outsourcing and clinical operations is required. SME in outsourcing and monitoring biomarker work at external service providers (ESP) is required 2.Laboratory knowledge of immunoassays and\/or bioanalysis and\/or cellular biomarkers is needed. Experience working with global and US, EU and Asia ESPs and monitoring biomarker work and maintaining data flows (LIMS, DTS, etc.) are required. Method development and troubleshooting experiences for complex assays is also required. Knowledge of multiple technologies (e.g. mass spec, FACs, etc.), technology platforms and clinical biomarkers is desired 3.In-depth knowledge of the drug development process, biomarkers and working with translation clinical research 4.Strong strategy skills, global project management, problem solving, influ-encing, communication and leadership skills. 5.Ability to work effectively under deadlines and high pressure and resolve complex issues with many global projects and clinical teams across multi-ple R&D sites. Experiences with root cause analysis related to bio analyti-cal work and design of system solutions. 6.Expert knowledge of regulatory compliance and health authority regula-tions (e.g. GLP, GCP, human tissues, privacy, etc.) related to clinical bi-omarkers is required 7.Potential, and willingness, to develop skills in new areas and lead new strategic initiatives

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Translational Medicine

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