The Medical Director, Clinical Pathologist/Laboratory Medicine provides medical consultative and interpretive support to Labcorp biopharma solutions and its internal and external customers. The Medical Director is responsible for medical decision-making and consultation related to laboratory services and clinical trials. Duties include providing leadership in areas of expertise of clinical pathology/laboratory medicine (e.g. clinical biochemistry, immunology, genomics), offering consultative medical guidance to our internal colleagues and external clients, and bridging laboratory operations and commercial teams.
Working on the Medical Affairs team involves frequent collaboration with a group of medical directors/pathologists and colleagues at our locations in the US, EU and Asia/Pacific. This opening offers a clinical pathologist/laboratory medicine the opportunity to build global experience and pursue a promising career at the cutting edge of drug development.
I. Duties and Responsibilities:
Provide leadership in areas of expertise of clinical pathology/laboratory medicine (clinical biochemistry, hematology, immunology, genomics, other).
Consult with Quality Assurance to ensure compliance with applicable regional, national (including Japan unique), 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.
Assist with the laboratory, medical, or other company functions that require a clinical pathologist, including analyses of and response to medical or laboratory/clinical trials inquiries by customers.
Maintain CAP laboratory accreditation compliance and lead site's proficiency testing (PT) activities.
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, as needed and as per educational qualifications.
Participate in the review and/or approval of new test or new service feasibilities.
Support company's business development activities (in Japanese language) and growth strategy.
Participate in business development visits to current and potential clients as required.
Bridge the communication between laboratory and commercial teams and iaison 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.
II. Education/Qualifications:
Required:
This physician executive position requires a Doctor of Medicine degree or equivalent with eligibility for full local licensure.
Training and local board eligibility or equivalent requirements for certification in clinical pathology/laboratory medicine.
Excellent interpersonal skills and the ability to communicate comfortably with individuals at all levels from a multitude of educational, scientific, professional backgrounds.
Ability to effectively interact with clients at meetings and conferences is essential.
Strong written and verbal communication skills in both English and Japanese are essential.
Preferred:
Additional training or certification / eligibility in recognized fields related to clinical trials testing performed at Labcorp.
Language Skills Required:
Speaking: English and Japanese, both fluent
Writing/Reading: English, Japanese, both fluent
Command of other languages (e.g. Chinese or Korean) is a plus but not required.
III. Experience:
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.
Experience with immunology, genomics, biomarkers and cell and gene therapy is a plus.
Labcorp is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.
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Saitama Labcorp Full timeThe Medical Director, Clinical Pathologist/Laboratory Medicine provides medical consultative and interpretive support to Labcorp biopharma solutions and its internal and external customers. The Medical Director is responsible for medical decision-making and consultation related t ...
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