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. **Medical Director, ICL** **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. Our laboratories hold both CAP and ISO15189 certifications as appropriate. 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:** + 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. . **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 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. **Benefits of Working in ICON:** Our success depends on the quality of our people. That’s why we’ve made it a priority to build a culture that rewards high performance and nurtures talent. We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals – both ours and yours. We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans – and related benefits such as life assurance – so you can save and plan with confidence for the years ahead. But beyond the competitive salaries and comprehensive benefits, you’ll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change. ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below. \#LI-SK1 **What ICON can offer you:** Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: + Various annual leave entitlements + A range of health insurance offerings to suit you and your family’s needs. + Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. + Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being. + Life assurance + Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others. Visit our careers site (https://careers.iconplc.com/benefits) to read more about the benefits ICON offers. At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here (https://careers.iconplc.com/reasonable-accommodations) Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here (https://wd3.myworkday.com/icon/d/task/1422$1235.htmld) to apply