Medical Director, Clinical Pathologist - LabCorp Biopharma Laboratory Services
For this Shanghai-based leadership position, the Medical Director/Clinical Pathologist is required to drive quality and delivery of Medical Affairs services to both internal and external customers in the APAC region and global sites. The successful candidate will support the growing volume of new assay validations across the APAC region, with responsibility for reviewing and approving method validation data and reports, particularly in the areas of immunology and genomics biomarkers. Prior experience in Cell & Gene therapy will be considered a strong asset.
The Medical Director/Clinical Pathologist in Medical Affairs provides medical consultative and interpretive support to LabCorp Central Laboratory Services and its internal and external customers. The Medical Director/Clinical Pathologist is responsible for medical decision-making and consultation related to laboratory services and pharmaceutical clinical trials. Additional responsibilities include consulting with Quality Assurance, Safety Committee, Investigator Site Support, Project Management, Sponsors, and Investigators.
I. Duties and Responsibilities:
• Assist with the laboratory, medical, or other company functions that require a pathologist, including analyses of and responses to medical or pathology/laboratory/clinical trials inquiries by customers.
• Provide medical support and direction to the Laboratory Operations leaders, especially in the absence of the Senior Director, Medical Affairs.
• Consult with Quality Assurance to ensure compliance with applicable local, state, federal, and international regulations governing clinical reference laboratories, transport of clinical specimens, and pharmaceutical drug clinical trials.
• Serve as site CAP Certificate Holder, if necessary, and maintain CAP and ISO laboratory accreditation requirements
• Assist in interfacing with Sponsors and/or Regulatory authorities as needed.
• Assist in the scientific professional growth of laboratory employees.
• Collaborate with others in the organization in the creation and approval of reference ranges and appropriate test/method selection for a given clinical indication.
• Review abnormal peripheral blood smears and other laboratory testing, as assigned.
• Advise in the development and approval of the technical database, the proprietary clinical trials database, and laboratory information systems.
• Participate in the review and/or approval of new test or service feasibilities.
• Participate in business development visits to current and potential clients, as required.
• Make presentations and represent the company at professional meetings and with prospective and existing clients, as required.
• As needed or requested, participate in investigator meetings or client visits to provide medical and laboratory support required for the success of a pharmaceutical drug clinical trial and submission of laboratory data to the FDA and other regulatory authorities.
• Pursue continuing or medical education in order to remain current in technology advances in the areas of laboratory medicine and clinical trials.
