Director of Clinical Affairs- Diagnostics

Responsibilities: Develop and lead clinical affairs strategy aligned with product development, regulatory, and post-market evidence needs Lead clinical study design, planning, execution, monitoring, and reporting including timelines, budgets, and risks Develop, review, and approve clinical study documentation including protocols, reports, and regulatory support materials Oversee clinical site selection, start-up, conduct, and close-out ensuring data quality and compliance Ensure studies comply with applicable regulations, standards, and internal procedures Manage Clinical Affairs personnel, external partners, and vendors while supporting team development Partner with Regulatory Affairs to support submissions and clinical evidence requirements Collaborate cross-functionally with R&D, Quality, Manufacturing, Medical/Scientific, and Marketing Improve clinical processes, metrics, and governance practices to support efficiency and data integrity Represent Clinical Affairs in leadership discussions and provide updates, risk assessments, and recommendations Experience &

Requirements: 10-15+ years of experience in the IVD (in vitro diagnostics) sector Experience with point-of-care and critical care technologies Experience managing or performing clinical trials and evaluations Experience preparing scientific publications and presenting at conferences or seminars Experience developing and managing Key Opinion Leader relationships Familiarity with international clinical standards and regulations including ISO 14155, ISO 20916, or ICH E6 Compensation & Benefits$225,000-$235,000 salary$20% performance based annual bonus 401K company match Flexible medical, dental, and vision coverage Tuition assistancePTO, paid holidays