Director, Medical Affairs

Company: Labcorp
Location: Indianapolis
Posted on: May 15, 2022

Job Description:

Director, Medical Affairs - - LabCorp Drug Development is a global contract research organization with the world's largest central laboratory network. - We employ over 50,000 people throughout 60 countries to support the pharmaceutical, biotechnology, and medical device industries. - As a leading provider of clinical trials solutions for all phases of development, we have contributed to each of the top 50 prescription drugs in the marketplace today. - Our offerings include dedicated support for companion diagnostics, genomics and molecular testing, vaccines support, immunotherapeutics, anatomic pathology and histology services, safety testing and hematology, chemistry, targeted cell isolation, hematopathology and flow cytometry. - - - There is an opening at our Indianapolis location. The Director, Medical Affairs provides medical consultative and interpretive support to Covance Central Laboratory Services and its internal and external customers. - The pathologist is responsible for medical decision-making and consultation that relate to laboratory services and clinical trials. - Additional responsibilities include consulting with Quality Assurance, Safety Committee, Investigator Site Support, Project Management, Sponsors, and Investigators. - 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 Vice President, Medical Affairs and/or the Executive Global Medical 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, serum and urine protein electrophoresis (SPEP/UPEP), 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.
• Pursue continuing or medical education in order to remain current in technology advances in the areas of laboratory medicine and clinical trials. - - Education and Qualifications: -Required:
  • This physician executive position requires a doctor of medicine degree with Indiana licensure and other states as required.
  • Board certification / eligibility in anatomic and clinical pathology by the American Board of Pathology.
  • Excellent interpersonal skills and the ability to communicate comfortably with individuals at all levels from a multitude of educational, scientific, professional and national or international backgrounds. Preferred:
    • Board certification / eligibility in one or more subspecialties by the American Board of Pathology.
    • Experience that satisfies the personnel requirement of CLIA 1988 or other applicable regulations for laboratory director.
    • Knowledge of clinical laboratory systems (testing, operations, finances, and information).
    • Must have laboratory management training or experience and demonstrate financial awareness. Labcorp is proud to be an Equal Opportunity Employer: As an EOE/AA employer, the organization will not discriminate in its employment practices due to an applicant's race, age, color, religion, sex, national origin, sexual orientation, gender identity, disability or veteran status. For more information about how we collect and store your personal data, please see our - -

Keywords: Labcorp, Indianapolis , Director, Medical Affairs, Executive , Indianapolis, Indiana