Clinical Affairs Director – Computed Tomography

About the role

The Clinical Affairs Director for Computed Tomography will lead evidence‑generation strategies, shape regulatory policy and drive business growth by translating clinical insights into product and market strategies.

Key responsibilities

• Lead cross‑functional clinical evidence programs and integrate scientific evidence into product development, lifecycle management and commercialization.
• Collaborate with Clinical Affairs, R&D, Regulatory, Medical, Marketing and external stakeholders to ensure strategic alignment.
• Build and maintain relationships with clinicians, KOLs, regulatory agencies and professional societies to inform strategy and adoption.
• Oversee real‑world evidence (RWE) strategy, data governance, and compliance with privacy and ethical standards.
• Provide leadership for clinical studies using real‑world data, ensuring scientific validity and regulatory acceptability.

Required profile

• 10+ years of experience in medical devices, biotech or pharmaceuticals, with direct sponsor experience.
• People‑leadership experience is mandatory.
• Background in radiology‑related devices or similar technologies.
• Strong knowledge of medical‑device standards and regulations (ISO, IEC, etc.).
• Bachelor’s/Master’s in a scientific field; advanced degree preferred.

Required skills

• ISO standards
• IEC standards
• Real‑world evidence (RWE) methodology
• Clinical development strategy
• Clinical operations
• KOL engagement

What we offer

• Comprehensive total‑rewards benefits including generous PTO, 401k match up to 7%, HSA contributions, stock purchase plan and education reimbursement.
• Competitive salary range $171,000‑$273,000 plus potential annual incentive bonus and long‑term incentives.