The Clinical Biomarker Lead will be responsible for implementing the clinical biomarker strategy and execution for assigned program(s) Clinical Trial(s) and implementing the biomarker plan during clinical development.
The Clinical Biomarker Lead will collaborate with Research/Preclinical and Clinical Development on development of translational biomarker plans and inclusion of Clinical Biomarkers in clinical studies, including study design. The role will coordinate with Translational Data Sciences and Advanced Analytics to support quantitative pharmacological approaches during clinical development. The Clinical Biomarker Lead will manage work with CRO and/or collaborate with colleagues from Biomarker Labs to ensure fit-for-purpose validation of clinical biomarker assays prior to implementation. The Clinical Biomarker Lead serves as a key member of project teams, providing expert input to teams and guiding clinical development of novel biomarkers.