Director of Clinical Affairs, IVD Strategy & Trials

Sysmex Corporation in Lincolnshire, Illinois, is seeking a Director of Clinical Affairs to develop and execute clinical strategies for new and modified IVD products. You will oversee preclinical/clinical evaluations, ensure FDA/GCP/GLP compliance, and manage IRB-approved studies in the RACA Laboratory.

You will lead cross-functional teams, coordinate with internal Sysmex affiliates, and mentor staff to deliver high-quality clinical documentation and regulatory submissions.