Job Description
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. Provide functional SME, operational support to specialty CROs for safety, PD, exploratory and patient screening / enrollment biomarkers and Companion Diagnosis (CDx) development. In close collaboration with clinical study teams, select functional biomarker testing vendors for clinical studies with strong scientific and business rationale and a focus on quality. Solicit, review Statement of Work (SOW) from biomarker testing vendors; work with contract, legal specialists, procurement to ensure timely execution of contracts, SOWs, l...
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