Senior Director, Clinical Biomarkers - Miami, United States - Proclinical Staffing

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    Description
  • Education: PhD degree in Biology, Translational Medicine, or related life sciences areas.
  • 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.
  • Skills: Fluent in both verbal and written communication in Chinese and English.
  • 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.
  • Engage with external diagnostic providers and global regulatory agencies to establish CDx filing pathways and compliance strategies.
  • Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.