The Medical Director, Clinical Pathology in Medical Affairs provides medical consultative and interpretive support to Labcorp biopharma solutions and its internal and external customers. The pathologist is responsible for medical decision-making and consultation related to laboratory services and 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.
? 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.
? 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.
