Biomarker & Clinical Operations:
- Lead end-to-end biosample and biomarker operations for Phase 1 SAD/MAD and Phase 2 clinical studies.
- Coordinate biomarker assay development, validation, and sample management activities.
- Manage end-to-end biospecimen lifecycle: sample collection, site training, shipment logistics, processing, and data transfer.
CRO & Vendor Management:
- Serve as the primary liaison with CROs for study design, execution, and reporting.
- Select and oversee central and specialty biomarker labs, managing vendor contracting, SOWs, POs, timelines, and data deliverable milestones.
- Manage CRO and vendor relationships for biomarker assay outsourcing, sample logistics, and translational study execution.
Data Management & Reporting:
- Partner with Data Management to ensure clean, reconciled, analysis-ready biomarker datasets are delivered on time.
- Implement and optimize tracking systems and LIMS tools to manage workflows, sample inventory, and operational exceptions.
- Develop reusable SOPs, tracking tools, and reconciliation workflows to scale operations across the portfolio.