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As a CLS/CGMBS at Inocras, you will be performing clinical laboratory testing for a whole genome Next Generation Sequencing (NGS) assay in order to provide doctors and patients complete genetic profiles for cancer and rare diseases.
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The Specimen Accessioner will be responsible for performing clinical specimen accessioning, sample sorting and data entry in a fast-paced, high-throughput environment according to established standard operating procedures.
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Oversee the implementation of specific biomarker and exploratory sample collection and analyses in all relevant clinical studies in selected programs. We are seeking to hire a Senior level Precision Medicine Strategy Lead (PMSL) to oversee the development and execution of biomarker strategies for the burgeoning Oncology Portfolio in Clinical Development at Regeneron.
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Cryopreserve cell therapy samples from clinical trials and development programs. Draft/revise SOPs and work instructions for sample management activities. Support sample management for routine in-process testing.
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Define business operation model for the virology lab (i.e. capacity planning, activity scheduling, sample projection, and metrics. This role is responsible for overseeing routine virus and mycoplasma testing (cell-based and molecular biology assays) of manufactured commercial and clinical products according to cGMP, ICH guidelines, and associated standard operating procedures.
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Lead biomarker and pharmacokinetic planning, definition, and implementation, overseeing sample collection for early and late-phase clinical trials. Extensive oncology experience, including proficiency in target/disease biology, preclinical, and clinical development.
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Proclinical Staffing is seeking a Senior Director, Clinical Biomarkers to join an innovative biotech company. Senior Director, Clinical Biomarkers - Permanent - Remote. Develop and enforce operational standards for biomarker management, vendor relations, and internal processes to ensure program quality, efficiency, and regulatory compliance.
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Professional Knowledge: Thorough understanding of diagnostic technologies, global regulatory frameworks, and biomarker applications in drug development. Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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Engage with external diagnostic providers and global regulatory agencies to establish CDx filing pathways and compliance strategies. Education: PhD degree in Biology, Translational Medicine, or related life sciences areas.
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Skills: Fluent in both verbal and written communication in Chinese and English. Develop strategic plans to meet budgetary requirements and successfully integrate companion diagnostic assays into end-of-life trials.
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Manage study budgets and financial transactions with vendors, ensuring effective resource allocation and cost management. This is a permanent role with the opportunity to work remotely. Collaborate closely with internal and external teams to ensure timely project delivery and alignment with objectives.
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Work Experience: Minimum 5 years in translational medicine; 10 years preferred. If you are having difficulty in applying or if you have any questions, please contact. Proclinical Staffing is an equal opportunity employer.
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If you are having difficulty in applying or if you have any questions, please contact Sofia Amark at (+1) 646-367-2764 or s.amark@proclinical.com.
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If you are having difficulty in applying or if you have any questions, please contact Sofia Amark at (+1) 646-367-2764 or s.amark@proclinical.com.
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If you are having difficulty in applying or if you have any questions, please contact Sofia Amark at (+1) 646-367-2764 or s.amark@proclinical.com.
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