Sr. Director, Clinical Development

Sr. Director, Clinical Development leads the clinical study portfolio across DELFI's development programs, working with R&D, medical, quality, and regulatory to define and execute the strategy for clinical studies supporting product development, launch, and reimbursement. Develops and oversees clinical study development and operations, manages CROs/investigators, designs case-control and prospective studies with input from Biostatistics, maintains timelines and budgets, and interfaces with FDA for IVD product submissions. Works with Medical Affairs to identify evidence gaps, collaborates with Data Engineering on clinical data curation, and participates in industry groups such as BLOODPAC and the Global Alliance for Genomics and Health. Requires a PhD or MD with 8+ years in clinical study design/development (and 3–5 years in IVD diagnostics), plus experience with regulatory standards (ICH E6(GCP), ISO 13485), and strong leadership and communication skills. Start-up mindset, proactive and decisive, with a track record of delivering robust evidence for diagnostics products in oncology and lung cancer contexts.