Biomarker Technical Expert

The role supports and executes translational science and biomarker operational strategies within clinical trials. The position works cross-functionally to ensure high-quality biomarker sample collection, data delivery, and analysis in compliance with regulatory and quality standards, while serving as a central coordination point for biomarker operations.

• Collaborate closely with Translational Science Leads (TSL), Clinical Operations, Biostatistics/Bioinformatics, and Data Management teams to support translational science strategies in clinical trials.
• Provide operational input into study-related documents and processes, ensuring biomarker sample collection, delivery, and analysis are conducted in accordance with study documentation and GCP/ICH guidelines.
• Serve as the single point of contact for biomarker operations across internal functions, external collaborators, and CROs.
• Provide biomarker operational expertise and guidance to study teams, ensuring learnings are shared across studies and programs, and identifying opportunities for best practices and process improvements.
• Partner with Data Management to support the setup and use of biomarker-relevant data collection pages, coordinate biomarker data formats and delivery timelines, and establish data transfer specifications.
• Ensure timely and efficient biomarker data delivery, including data transfers, reconciliation, analysis, and reporting.
• Coordinate mutual data transfers with Companion Diagnostics (CDx) partners to support CDx regulatory submissions, as needed.

• Experience working in clinical trial operations, biomarker operations, or translational science support.
• Strong understanding of GCP/ICH guidelines and clinical trial documentation processes.
• Proven ability to work cross-functionally with clinical, scientific, and data teams.
• Experience coordinating biomarker sample and data workflows, including data transfers and reconciliation.
• Strong organizational, communication, and stakeholder management skills, including interaction with CROs and external partners.