The Clinical Pathologist (Laboratory Medicine), and/or Anatomic Pathologist, 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 central laboratory services and clinical trials. Duties include providing leadership in areas of expertise of clinical pathology/laboratory medicine (e.g. clinical biochemistry, immunology, genomics), and/or anatomic pathology and histology (e.g. immunohistochemistry - IHC, ISH, FISH, digital pathology), offering consultative medical guidance to our internal colleagues and external clients, and bridging laboratory operations, medical experts/pathologists, and commercial teams.
We are seeking candidates who are interested either in full-time employment, or in part-time (e.g. 2-3 days per week), or as an independent contractor (pathologist consultant). Working on the Medical Affairs–Pathologist team involves frequent collaboration with a group of pathologists and colleagues at our locations in the US, Europe, and Asia Pacific. This opening offers a pathologist the opportunity to build global experience and pursue a promising career path at the cutting edge of drug development.
Duties and Responsibilities:
- Provide leadership in areas of expertise of clinical pathology (laboratory medicine) (e.g. clinical biochemistry, hematology, immunology, genomics, other) and/or anatomic pathology (e.g. immunohistochemistry - IHC, ISH, dISH, FISH, digital pathology)
- Consult with Quality Assurance to ensure compliance with applicable country-level, regional, and international regulations, in governing clinical laboratories, transport of clinical trial specimens, and pharmaceutical drug clinical trials.
- Oversee medical decisions and fulfill regulatory and laboratory duties requiring a pathologist.
- Review of tissue slides for anatomic pathologist’s diagnostics or interpretation.
- Review abnormal peripheral blood smears and serum protein electrophoresis (SPEP), as assigned and per background educational qualifications.
- As needed or requested, participate in pathologist training for Companion diagnostic (CDx) studies to provide anatomic diagnostic services required for the success of CDx clinical trials.
- Assist with the laboratory, medical, or other company functions that require a pathologist, including analyses of and response to medical or technical or laboratory/clinical trials inquiries by customers.
- Support CAP laboratory accreditation compliance and lead site’s proficiency testing (PT) activities.
- Collaborate with others in the organization in the creation and approval of reference ranges and appropriate test/method selection for a given clinical indication.
- Participate in the review and/or approval of new test or new service feasibilities.
- Support company’s business development activities and growth strategy.
- Participate in business development visits to current and potential clients as required.
- Bridge the communication between laboratory and commercial teams and liaison with medical experts/pathologists of collaborating laboratories.
- Collaborate with business development in review, writing, presentation, and defense proposals.
- Assist in interfacing with sponsors and/or regulatory authorities as needed.
- 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.
- Other duties as assigned.
Required:
- Experience that satisfies personnel requirements and/or other applicable regulations to perform the duties of a clinical pathologist / laboratory medicine.
- Knowledge of clinical laboratory systems (testing, operations, finances, and information).
- Have laboratory management training or experience and demonstrate financial awareness.
- Completion of a pathology residency for clinical pathologist or anatomic pathologist.
- Minimum 5 years’ qualifying working experience in a clinical testing or pathology laboratory.