Kelonia Therapeutics

Director

• Set the vision, direction, and strategy for Data Management (DM) across clinical development portfolio
• Oversee the planning, execution and quality assurance of clinical data management activities
• Collaborate within the function and cross-functionally to resolve data management issues
• Proactively identify and manage risks for the DM function
• Serve as internal DM expert for outsourcing strategy
• Ensure data quality/integrity and regulatory compliance for DM processes
• Drive SAP and programming timelines to meet deliverables
• Represent function in external professional initiatives to identify best practices

Director, Clinical Data Management

Operations

• Lead global central laboratory operations across Phase I–III clinical trials, serving as the primary contact for specimen and sample management issues
• Direct and oversee performance of central laboratories across clinical trials
• Oversee end-to-end biospecimen tracking, reconciliation, and chain-of-custody processes to ensure data integrity and audit readiness
• Direct and oversee clinical lab kit design, ordering, and inventory management
• Direct external central, specialty, and imaging laboratory activities across multiple clinical programs, managing logistics for high-volume specimen processing
• Design, implement, and continuously improve sample management systems and processes to enhance efficiency, reduce reconciliation errors, and streamline turnaround times
• Leverage data analytics, automation, and emerging technologies (including AI-enabled tools where appropriate) to improve sample tracking, reconciliation accuracy, and turnaround time across global clinical trials
• Ensure compliance with ICH-GCP, GxP, FDA inspection readiness requirements, and global biospecimen shipping regulations
• Lead vendor qualification, selection, and due diligence activities for laboratory and imaging providers
• Negotiate, initiate, and manage laboratory service agreements, Data Transfer Agreements (DTAs), and related contracts
• Partner with QA to support vendor qualification audits and regulatory inspections
• Monitor vendor performance through KPIs and proactively resolve laboratory-related issues, driving corrective and preventive actions (CAPAs) as needed
• Collaborate with Clinical Development colleagues to integrate and operationalize bioanalytical testing strategies into clinical protocols and support patient identification and enrollment
• Partner with Regulatory Affairs to ensure laboratory strategies align with protocol requirements and regulatory expectations
• Coordinate sample-related data transfers and internal data exchange between testing laboratories, CROs, and Data Management teams
• Develop and maintain laboratory and imaging manuals; provide guidance and training to study coordinators and investigators as appropriate
• Define lab-related project timelines, mitigate risks, and ensure on-time, on-budget execution of sample and data deliverables
• Represent the company in laboratory partner meetings and maintain strong, collaborative relationships with external vendors and stakeholders
• Contribute to strategic planning, forecasting, and operational KPI development aligned with corporate goals

Director, Clinical Data Management

Associate Director/Director, Clinical Bioanalytical Lab Operations