Client Details
Job Position : Clinical Biomarker & Diagnostics Quality
Client : BeOne Medicines
Duration : 12 Months
Job Summary:
• The Senior Consultant, Clinical Biomarker & Diagnostics Quality is a dedicated, full-time, hands-on R&D Quality resource supporting BeOne's United States clinical biomarker laboratory and related diagnostic activities across the development pipeline.
• The engagement is focused on the day-to-day Quality review, approval, qualification, validation, and implementation of laboratory equipment, instruments, associated software, analytical methods, procedures, and controls.
• The consultant will apply phase-appropriate GCLP expectations based on intended use, data criticality, and the potential impact of results on clinical-development decisions, participant protection, and patient safety.
• The primary focus is the San Carlos Biomarker Laboratory, including exploratory, pharmacodynamic, translational, and clinically relevant assays that may inform dose escalation, cohort decisions, early-phase study design, or other clinical-development decisions.
• The role will ensure that assay lifecycle controls, sample identity and traceability, data integrity, method execution, result review and reporting, laboratory procedures, and inspection-ready documentation are fit for purpose and consistently maintained.
• The consultant will also serve as the dedicated independent R&D Quality representative for implementation of the validated BIOVIA Electronic Laboratory Notebook solution for the U.S. Biomarker Laboratory. This includes Quality oversight and approval of requirements, risk assessments, configuration and design documentation, qualification and validation testing, traceability, system release, procedural readiness, go-live, hypercare, and continued maintenance of the validated state. Where experience and capacity permit, the role may additionally support investigational diagnostic, IVD, or companion diagnostic activities in later-phase clinical development. Expert GCLP and clinical biomarker laboratory Quality experience is required; clinical-trial diagnostic and IVD/CDx experience is strongly preferred.
Required Qualifications:
Clinical Biomarker Laboratory Quality Support
• Serve as the dedicated R&D Quality partner for the San Carlos Biomarker Laboratory and related U.S. clinical biomarker activities supporting BeOne's development pipeline.
• Provide timely, practical, and risk-based Quality guidance for laboratory qualification, implementation, routine operations, issue resolution, change management, deviations, investigations, CAPAs, and inspection readiness.
• Review and approve laboratory procedures, work instructions, forms, specifications, protocols, reports, and quality records associated with GCLP or clinically relevant biomarker testing.
• Assess laboratory readiness and ensure appropriate controls for personnel qualification and training, materials and reagents, sample receipt and chain of custody, sample identity, storage, method execution, run acceptance, data review, result reporting, record retention, and archival.
Equipment, Instrument, and Computerized-System Qualification
• Lead the independent Quality review and approval of qualification and validation documentation for laboratory equipment, instruments, instrument software, data-analysis applications, and associated infrastructure.
• Review and approve intended-use statements, user and functional requirements, risk assessments, validation or qualification plans, design assessments, IQ/OQ/PQ or equivalent testing, traceability matrices, deviations, reports, release recommendations, and supporting evidence.
• Evaluate vendor documentation and determine whether supplemental BeOne testing or assurance is required based on intended use, system complexity, data criticality, and risk.
• Confirm appropriate controls for calibration, preventive maintenance, access and security, audit trails, electronic records, backup and recovery, business continuity, interfaces, data transfer, configuration, change control, and system retirement.
Biomarker Assay and GCLP Oversight
• Provide Quality oversight for exploratory, pharmacodynamic, translational, and clinical biomarker assays used in nonclinical and clinical development.
• Review assay intended use, development and qualification strategies, analytical validation plans, acceptance criteria, quality-control strategy, reference standards, method transfer, bridging, changes, deviations, and final reports.
• Apply phase-appropriate GCLP controls, with increased rigor where assay results may influence dose escalation, cohort selection, early-phase clinical decisions, participant management, or later regulatory use.
• Ensure end-to-end traceability from sample collection and receipt through processing, analysis, review, reporting, data transfer, and archival.
BIOVIA Electronic Laboratory Notebook Implementation
• Serve as the primary independent R&D Quality representative for implementation and lifecycle oversight of the validated BIOVIA ELN solution for the U.S. Biomarker Laboratory.
• Provide Quality oversight of platform configuration and validation, BIOVIA Workbook configuration, CISPro sample-management integration, laboratory workflow automation, and controlled role-based user access.
Clinical Diagnostics and IVD/CDx Support
• Where experience and capacity permit, provide Quality support for diagnostic assays used for patient selection, stratification, enrollment, or other later-phase clinical-trial decisions.
• Support the transition of selected biomarker assays from exploratory or clinical use toward investigational IVD, IVD, or companion diagnostic applications.
Partnership and Delivery
• Work closely with Biomarker Laboratory leadership, Translational Medicine, Clinical Development, Clinical Operations, Diagnostics, Regulatory Affairs, Global Technology Solutions, validation teams, and external laboratories and vendors.
• Escalate significant quality, data integrity, patient-safety, validation, or implementation risks promptly and recommend proportionate corrective or preventive actions.