We are currently seeking a Senior Director, Medical Affairs - Pathologist to join our team. Reporting to the Vice President, Global Testing Services and Medical Affairs, the incumbent will provide medical consultative and interpretive support to Covance Central Laboratory Services globally and its internal and external customers. The incumbent is responsible for the oversight of medical decision-making and consultation that relate to laboratory services and clinical trials across all sites globally. Additional areas of oversight include consulting with Quality Assurance, Safety Committee, Investigator Site Support, Project Management, Sponsors, and Investigators. The Sr. Med Director will hold the position of team expert and go-to Pathologist and will advise and contribute to final decisions regarding clinical areas of the business. Other areas of responsibilities include;
Laboratory Operations support:
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)
Provide expert input 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.
Key leader in the review and/or approval of new test or service feasibilities.
Contribute to scientific publications.
Business development and support:
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.
Collaborate with business development in review, writing, presentation and defense proposals