Manager/Senior Manager, Biomarker & Biospecimen Operations

Role: Senior Manager/Manager, Biomarker & Biospecimen Operations at a clinical-stage biotech developing cancer immunotherapies, focusing on biospecimen logistics throughout clinical trials. Responsibilities include managing biospecimen collection, shipment, inventory, and documentation; developing operational plans; collaborating with Clinical Operations, vendors, and internal teams to ensure specimen integrity, compliance, and inspection readiness; reconciling data and resolving discrepancies; overseeing external vendors and laboratories; and ensuring adherence to regulations like ICH-GCP, FDA, and EMA. Qualifications: Bachelor's in Life Sciences or related field; 5+ years (Manager) or 8+ years (Senior Manager) in clinical trial biospecimen management, with experience in biomarker sample handling, laboratory operations, and regulatory standards. Preferred: experience in late-stage solid tumor oncology, biomarker assay technologies (flow cytometry, genomics, proteomics), and familiarity with biospecimen guidance and regulatory submissions. The role involves cross-functional collaboration with Translational Medicine, Clinical Ops, Data Management, and external vendors, with a focus on process standardization, operational excellence, and compliance. Location: Remote; no sponsorship required.