Medical Director, Laboratory

Medical Director, Laboratory- Farmingdale, New York

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Medical Director, Laboratory

The role:

As the Medical Director of a High Complexity Clinical Laboratory, you are responsible for the overall oversight, management, and direction of medical and scientific aspects of the laboratory operations. This role ensures compliance with all regulatory and accreditation requirements, guides clinical decision-making, and ensures that the laboratory’s testing services meet the highest standards of quality and patient care. Of note, many of the operational roles listed below can be delegated. Those that cannot be delegated, such as the Annual Safety Inspection and the review of Proficiency, must be performed by the Medical Director.

Key Responsibilities include

Medical Oversight & Leadership:

• Provide clinical oversight and medical guidance for laboratory testing, ensuring all results and diagnoses are accurate and medically appropriate.
• Oversee the laboratory’s clinical activities to ensure patient safety and proper diagnostic procedures.
• Interpret test results, provide clinical consultation, and collaborate with other healthcare providers on test selections, result interpretations, and treatment plans.
• Stay informed about new medical advancements, technologies, and testing methodologies relevant to high-complexity clinical laboratories.

Regulatory Compliance & Accreditation:

• Ensure compliance with all relevant federal, state, and local regulations, including but not limited to CLIA (Clinical Laboratory Improvement Amendments), CAP (College of American Pathologists), and Joint Commission standards.
• Maintain laboratory accreditation by ensuring adherence to appropriate guidelines and policies.
• Prepare for and lead regulatory inspections and audits.
• Establish and enforce policies for quality control, quality assurance, and proficiency testing.

Staff Development & Training:

• Oversee the recruitment, training, and performance evaluation of laboratory personnel.
• Provide medical and scientific training to laboratory staff and ensure they are up to date with current best practices.
• Foster a culture of continuous learning, professional development, and high-quality patient care among laboratory personnel.

Quality Assurance & Improvement:

• Lead the implementation and oversight of quality assurance programs and initiatives such as the ICL Global QC Harmonization scheme and the monthly monitoring of KPI’s at each lab.
• Monitor laboratory performance and implement improvements based on data-driven insights.
• Lead root cause analysis and corrective action plans in response to any non-conformance, errors, or patient safety incidents.
• Lead risk management efforts, including identifying and mitigating risks related to laboratory testing, patient safety, and data integrity.
• Develop and implement protocols for addressing adverse events or near-miss incidents in the laboratory.

Clinical Consultation & Collaboration:

• Consistent with training and professional experience, provides scientific, technical and/or medical expertise to other departments within ICON laboratories including the specialty laboratory, project management, and business development departments. This expertise will include the interpretation, correlation and communication of the medical significance of laboratory data.
• Provide professional, scientific, consultative or advisory, organizational, administrative and educational matters relevant to the services offered. 

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Operational Leadership:

• Work with laboratory leadership to develop strategies and goals for the laboratory’s operation and growth.
• Assist in resource allocation, budgeting, and financial planning for the laboratory, ensuring efficient use of resources while maintaining high-quality services.
• Evaluate and recommend new technologies and laboratory equipment to improve testing services.

- Recognize, exemplify and adhere to ICON's values which center on our commitment to People, Clients and Performance.

- Travel up to 15% of the time.

- Able to discharge the responsibilities described in Part 19.3© (1), (1) through (11) of 10 NYCRR (State of NY code of Rules and Regulations) and the College of American Pathologists’ requirements (as