Medical Director, Ireland
ICON plc is a leading healthcare intelligence and clinical research organization committed to innovation and excellence. We invite qualified professionals to join our inclusive team dedicated to shaping the future of clinical development.
Job Profile Summary
We are seeking a US- or EU-based Medical Director to support our global clinical trial testing through ICON Clinical Laboratories. The candidate may act as a license holder for multiple laboratories and must be qualified to oversee high-complexity laboratories as defined by CAP standards. Our laboratories are CAP and ISO15189 certified. Responsibilities include providing clinical and operational leadership to ensure compliance with regulatory, quality, safety standards, and addressing sponsor requests. Specialization and licensure in Clinical Chemistry or Biochemistry are highly desirable.
The Role
As Medical Director, you will oversee the medical and scientific aspects of laboratory operations, ensuring regulatory compliance, guiding clinical decisions, and maintaining high standards of quality and patient care. Some operational tasks may be delegated, but critical responsibilities like safety inspections and proficiency reviews are mandatory for the Medical Director.
Key Responsibilities
Medical Oversight & Leadership
* Provide clinical oversight and guidance for laboratory testing.
* Ensure patient safety and proper diagnostic procedures.
* Interpret test results and collaborate with healthcare providers.
* Stay updated on medical advancements relevant to high-complexity labs.
Regulatory Compliance & Accreditation
* Maintain adherence to CLIA, CAP, and other standards.
* Lead inspections and audits.
* Develop policies for quality control and assurance.
Staff Development & Training
* Manage recruitment, training, and performance of staff.
* Provide ongoing education and foster a culture of excellence.
Quality Assurance & Improvement
* Lead quality programs and monitor KPIs.
* Implement improvements and corrective actions.
* Manage risks related to testing and safety.
Clinical Consultation & Collaboration
* Provide scientific and medical expertise across departments.
* Interpret and communicate laboratory data significance.
Operational Leadership
* Develop operational strategies and goals.
* Assist in resource planning and technology evaluation.
Travel up to 15% may be required. The candidate must meet specific regulatory and accreditation standards as per NYCRR and CAP guidelines.
Experience & Qualifications
Education:
* MD or DO with an unrestricted US medical license.
* Board-certified in Pathology, Clinical Pathology, or relevant specialty.
* Additional certifications like Clinical Laboratory Director are preferred.
Experience:
* At least 5 years in a high-complexity clinical lab, with 2+ years in a director role.
* Proven compliance with standards like ISO15189, CLIA, CAP.
* Experience leading quality and safety programs.
This role may evolve, and additional responsibilities may be assigned.
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