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Scientist, Biomarkers
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- Key Responsibilities Collaborate with preclinical/clinical study teams to develop Clinical Biomarker Strategy Plans.
- The Clinical Biomarker Lead will be accountable for robust clinical biomarker strategic, operational planning, and execution in support of oncology clinical programs for novel biologic drugs (eg TCE, ADC) starting from preclinical stage through Phase 1/2 clinical trials.
- Deliver biomarker specimen and testing strategy in accordance with the requirements of quality, ethical and regulatory standards, including ICH/GDPR/GXP and CAP/CLIA guidance.
- Responsible for forging and managing strong relationships with vendors to ensure timely clinical sample receipt, sample testing and biomarker data transfers to meet downstream data analysis timelines.
- In close collaboration with CRO, CTM/CTA ensure biomarker specimen handling and processing steps are appropriately described in the Clinical Lab Manuals for collection, processing, and shipping of patient samples.
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