Medical Director, Laboratory

2 weeks ago

Dublin, Dublin City, Ireland Icon Full time

Medical Director, Ireland ICON plc is a world-leading healthcare intelligence and clinical research organization.
We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

Job Profile Summary ICON Clinical Laboratories is seeking a US - or EU-based Medical Director to join our Medical Affairs team supporting clinical trial testing globally.
The individual filling this position may act as a license holder for more than one ICL laboratory and must be qualified by training and experience to fulfill the duties and responsibilities for a Director of a High Complexity Laboratory as defined by the College of American Pathologists.

Responsibilities include providing clinical and operational leadership to ensure that clinical, regulatory, quality, and patient and staff safety standards are met, as well as addressing specific requests for individual trial sponsors.
Individuals with a specialty and licensure in Clinical Chemistry or Biochemistry are especially desirable.

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: Provide scientific, technical and/or medical expertise to other departments within ICON laboratories including the specialty laboratory, project management, and business development departments.
Provide professional, scientific, consultative or advisory, organizational, administrative and educational matters relevant to the services offered.
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 , (1) through (11) of 10 NYCRR (State of NY code of Rules and Regulations) and the College of American Pathologists' requirements (as stated in the "Laboratory Director Assessment" Inspection Checklist).

Experience & Qualifications: Education: MD or DO degree with a valid and unrestricted U.S. medical license.
Board-certified in Pathology, Clinical Pathology, or another relevant specialty (e.g., Medical Microbiology, Clinical Chemistry).
Additional qualifications or certifications in laboratory medicine are preferred (e.g., Clinical Laboratory Director certification).
Experience: Minimum of 5 years of experience in a high-complexity clinical laboratory, with at least 2 years in a medical director role.
Proven track record of compliance with regulatory standards and accreditation processes (e.g., ISO15189, CLIA, CAP).
Experience in leading quality assurance, quality control, and patient safety programs.
This job description outlines the primary responsibilities and qualifications for the Medical Director of a High Complexity Clinical Laboratory.
Duties may evolve over time, and additional responsibilities may be added as needed.

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