Clinical Affairs Director
Core
Lead clinical evidence programs, regulatory policy, and real-world evidence strategies for Computed Tomography devices to support product lifecycle and commercialization.
Role type
Senior IC Clinical Affairs Director (Medical Devices)
Builds
Clinical evidence programs, regulatory strategies, and real-world evidence (RWE) initiatives for CT imaging products.
Domain
Medical Devices / Radiology / Healthcare Technology
Required skills
People leadership, clinical development strategy, clinical operations, medical affairs KOL engagement, regulatory standards knowledge (ISO/IEC), real-world evidence strategy, cross-functional collaboration
Preferred skills
Advanced degree in Science, experience in biotech/pharma sponsor roles
Technologies
ISO, IEC, RWE data platforms
Responsibilities
Drive succession planning and talent management for clinical teams; Translate clinical research insights into product and business strategies; Direct cross-functional collaboration with R&D, Regulatory, and Marketing; Build strategic relationships with clinicians, KOLs, and regulatory agencies; Oversee RWE strategy development and governance; Lead clinical studies incorporating real-world data.
Seniority
Senior, hands-on IC with people leadership