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Associate Director, Biomarker Operations
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$152,000 - $209,000 a year
Full-time
- Reporting to the VP, Clinical Operations, the Associate Director, Biomarker Operations is responsible for understanding the scientific strategy and implementation of biomarker assays to support clinical programs.
- This is a leadership position that has extensive experience in the following areas: Biomarker/Diagnostic Assay Development and Analysis Expertise, Clinical Trial Operations, Procedures and Regulations, Biospecimen Management, Vendor Sourcing & Contracting, Informed Consent (ICF) Design & Interpretation, Central and Specialty Lab Testing and Management.
- This individual is responsible for working with the Study Operations, Procurement, Business Operations, Clinical and Translational Medicine, Clinical Data Management, Legal, GCP Compliance, Quality, and Research teams to ensure a smooth process flow for all biomarker-related activities.
- Provides biomarker and diagnostic project management and operations leadership across multiple clinical programs after Research & Early Development colleagues define the scientific path forward
- Collaborates with Clinical Development for on site trainings for biomarker sample management logistics, sample and testing questions from sites, IRBs, and ethics committees
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