ProClinical Staffing

Professional Knowledge: Thorough understanding of diagnostic technologies, global regulatory frameworks, and biomarker applications in drug development.. Extensive oncology experience, including proficiency in target/disease biology, preclinical, and clinical development.. Lead biomarker and pharmacokinetic planning, definition, and implementation, overseeing sample collection for early and late-phase clinical trials.. Develop and enforce operational standards for biomarker management, vendor relations, and internal processes to ensure program quality, efficiency, and regulatory compliance.. Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

senior director

﻿Senior Director, Clinical Biomarkers - Permanent - RemoteProclinical Staffing is seeking a Senior Director, Clinical Biomarkers to join an innovative biotech company. This is a permanent role with the opportunity to work remotely.Skills & Requirements:<ul><li>Education: PhD degree in Biology, Translational Medicine, or related life sciences areas.</li><li>Professional Knowledge: Thorough understanding of diagnostic technologies, global regulatory frameworks, and biomarker applications in drug development.</li><li>Work Experience: Minimum 5 years in translational medicine; 10 years preferred. Extensive oncology experience, including proficiency in target/disease biology, preclinical, and clinical development.</li><li>Skills: Fluent in both verbal and written communication in Chinese and English.</li></ul>The Senior Director, Clinical Biomarkers will:<ul><li>Lead biomarker and pharmacokinetic planning, definition, and implementation, overseeing sample collection for early and late-phase clinical trials.</li><li>Develop and enforce operational standards for biomarker management, vendor relations, and internal processes to ensure program quality, efficiency, and regulatory compliance.</li><li>Manage study budgets and financial transactions with vendors, ensuring effective resource allocation and cost management.</li><li>Develop strategic plans to meet budgetary requirements and successfully integrate companion diagnostic assays into end-of-life trials.</li><li>Collaborate closely with internal and external teams to ensure timely project delivery and alignment with objectives.</li><li>Engage with external diagnostic providers and global regulatory agencies to establish CDx filing pathways and compliance strategies.</li></ul>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.comProclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.Proclinical Staffing is an equal opportunity employer.

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