SVP, Chief Medical Officer at BioReference Labs in Elmwood Park, New Jersey

Job Description:

Company Overview

This is an exciting time to join our dynamic organization! BioReference, an OPKO Health company, is the largest full service specialty laboratory in the United States that gives healthcare providers and patients the power to make confident healthcare decisions. With a focus on oncology, urology and women's health, BioReference offers comprehensive test solutions and unparalleled expertise based on a 40 year legacy of proven science and exceptional service. Join our team and become part of the journey in making our patients and customers the highest priority.

Job Description

Reporting to the Chief Executive Officer, the Chief Medical Officer is responsible for assisting in the overall operation and administration of the clinical laboratory. The Chief Medical Officer will review validations, review and sign off on lab tests, and will review clinical diagnostic platforms and recommend specific types of testing in consultations. They will work closely with the Chief Executive officer and will be involved in planning and choosing instrumentation for new environment is essential to being successful in this role.

Position and Responsibilities:

Duties may include but are not necessarily limited to the following:

• Must be available to provide and ensure that consultation is available on test ordering, and interpretation of results related to specific patient conditions, and for matters related to the quality of test results reported.


• Ensures communication of laboratory data and appropriate patient result reporting.


• Responsible for assisting in the overall operation and administration of the clinical laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulation.


• Ensure that testing systems developed and used for each of the tests performed in the laboratory provide quality laboratory services for all aspects of test performance, which includes the pre-analytic, analytic, and post-analytic phases of testing.


• Ensure that the test methodologies selected have the capability of providing the quality of results required for patient care; verification procedures used are adequate to determine the accuracy, precision and other pertinent performance characteristics of the method; and laboratory personnel are performing the test methods as required for accurate and reliable results.


• Ensure the establishment and maintenance of acceptable levels of analytical performance for each test system.


• Ensure that all necessary remedial actions are taken and documented whenever significant deviations from the laboratory's established performance specifications are identified and that patient test results are reported only when the system is functioning properly.


• Ensure that reports of test results include pertinent information required for interpretation.


• Ensure that consultation is available to the laboratory's clients on matters relating to the quality of the test results reported and their interpretation concerning specific patient conditions.


• Ensure that prior to testing patient specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered and have demonstrated that they can perform all testing operations reliably to provide and report accurate results.


• Ensure that policies and procedures are established for monitoring individuals who conduct pre-analytical, analytical and post-analytical phases of testing to assure that they are competent and maintain their competency to process specimens, perform test procedures and report test results promptly and proficiently, and whenever necessary, identify needs for remedial training or continuing education to improve skills.


• Ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process


• Oversee the development of the organization's plans and programs in evaluation of long-range planning and regulatory action on operational performance. Foster a unified culture and promotes a process for collaboration, cooperation, sharing of information and mutual teamwork. This includes analysis of prospective new laboratories under the BioReference umbrella.


• Monitor utilization patterns of lab services and advises Leadership and other appropriate staff of developing trends in clinical service needs.


• Establish and maintain lines of communication with internal and external customers in order to ensure a timely response to new clinical service trends and program planning.

• Ensure operational adherence to currently accepted technical service standards for laboratory medicine.


• Ensure operational adherence to applicable policies and procedures by all technical and operational staff.


• Lead and direct the development, communication and implementation of effective growth strategies and processes.


• Perform other responsibilities as mandated by Clinical Laboratory Improvement Amendments (CLIA) and any other pertinent local, state or federal regulations.


• Review of Proficiency Results records.


• Review of inspection reports by regulatory agencies (State, CMS, CAP, and COLA).


• Review of variances such as non-conforming events, internal and external complaints, and PT failures.


• Assist with managing department budgets.


• Assists in special projects as directed by the Chief Executive Officer.

Required Credentials and Experience:

• MD or DO in good standing


• Board certified in Clinical Pathology (CP) or Anatomic and Clinical Pathology (AP/CP) by American Board of Pathology or Osteopathic Board of Pathology


• Minimum of 5 years of post-training experience in Clinical Pathology at a tertiary hospital medical center or large reference lab


• Must have active NJ and NY medical licensure


• Must have NJ BioAnalytic Laboratory Director License


• NYS Certificate of Qualification (CQ) as a Laboratory Director in core laboratory categories, such as chemistry, immunology, immunohematology, bacteriology


• A minimum of 5 years of experience in a managerial role

Required Qualifications:

• Ability to make complex scientific judgments


• Strong managerial and leadership skills

Strong communication skills both verbal and documentation

• Strong customer focus and understanding of laboratory operations


• Ability to communicate with high level decision makers in the organization


• Personal adaptability and ability to lead change

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