Medical Laboratory Director

About the role

The Medical Laboratory Director provides medical, scientific and technical leadership for IQVIA Laboratories' clinical testing operations, ensuring services meet regulatory, accreditation, quality and scientific standards while supporting global clinical research programs. The position is the designated Laboratory Director for IQVIA Laboratories in Singapore and Tokyo, working closely with Laboratory Operations, Scientific Affairs, Quality Assurance, Project Management, sponsors and investigators.

Key responsibilities

• Provide oversight of clinical laboratory testing and ensure compliance with regulatory, accreditation and quality requirements.
• Collaborate with Quality Assurance and operations to maintain and improve quality systems, processes and customer service.
• Escalate and support resolution of patient safety, quality and data integrity issues, including investigations, corrective actions and proficiency testing.
• Review and approve validation plans, protocols and reports for new assays before production use, and support the transition of trial assays to routine testing.
• Maintain testing menus, service directories and test coding structures, and provide scientific support during audits, bids and proposals.
• Support recruitment, onboarding and training of laboratory staff, and implement health, safety and environmental programs.
• Stay current with scientific and regulatory developments and take part in site leadership and governance activities.
• Support anatomic pathology activities where qualified and credentialed.

Required profile

• MD and/or PhD in Pathology, Laboratory Medicine, Biological Sciences, Health Sciences or a related discipline.
• Significant experience in clinical laboratory leadership, pathology, laboratory medicine or clinical research.
• Preferred: current registration with the Singapore Medical Council, board certification in Pathology, Laboratory Medicine or Clinical Pathology, and experience in a central laboratory, reference laboratory, CRO, pharma, biotech or clinical trials setting.
• Preferred: experience with CAP, ISO 15189, CLIA or similar accredited environments, and with accreditation assessments, audits and inspections.
• Japanese language proficiency is advantageous but not required.

Required skills

• Strong knowledge of clinical laboratory testing, quality management systems and accreditation requirements.
• Ability to lead multidisciplinary teams and communicate clearly in writing and verbally.
• Proficiency with Microsoft Office and relevant laboratory and business systems.