The Director, Medical Affairs provides medical consultative and interpretive support to Covance Central Laboratory Services and its internal and external customers. The incumbent 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.
Laboratory Operations support:
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, acting as first point of contact for US Central Labs.
Provide medical/pathology/clinical laboratory support to Laboratory operations departments and Investigators sites as needed.
Review abnormal peripheral blood smears and serum protein electrophoresis (SPEP), as assigned.
Regulatory and Compliance:
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.
Consult with Quality Assurance to ensure compliance with applicable local and international regulations governing clinical reference laboratories, transport of clinical specimens, and pharmaceutical drug clinical trials.
Assist in interfacing with Sponsors and/or Regulatory authorities as needed.
Assist in the scientific professional growth of laboratory employees (provide guidance for professional development of staff, participates in interviews, makes hiring recommendations, leads disciplinary actions, delivers performance appraisal review, as required)
Collaborate with others in the organization in the creation and approval of reference ranges and appropriate test/method selection for a given clinical indication.
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.
Pursue continuing or medical education in order to remain current in technology advances in the areas of laboratory medicine and clinical trials.
Contribute to scientific publications.
Business development and support:
As needed, interact with Sponsors and Medical Affairs group in protocol review and/or development
Perform literature review related to the therapeutic area involved in Sponsor clinical development
Communicate with clients and clients’ Project Managers to promote project schedule adherence within laboratory operations and meet high quality standards.
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
Collaborate with business development in review, writing, presentation and defense proposals