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
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