Director Clinical Affairs - European Markets

About the role

Intuitive, a leader in robotic-assisted surgery, is looking for a Director Clinical Affairs to develop and run clinical study strategies and plans for its products in European markets. The role works in a global matrix with regional and country leaders, Marketing, Medical Affairs, Market Access, Regulatory Affairs, Finance, Legal and Global Public Affairs, and leads teams on evidence generation and dissemination.

Key responsibilities

• Drive clinical evidence strategies for European markets and set priorities balancing short-term and long-term needs
• Lead company-sponsored, collaborative, investigator-initiated studies and evidence generation with medical/surgical societies
• Build relationships with KOLs, hospitals and societies, and review and approve clinical plans, reports and PMCF plans
• Hire, coach and develop the clinical affairs team, and provide leadership to the broader Clinical Affairs organization
• Ensure compliance with corporate and regulatory requirements (GCP, EU MDR, US FDA, data protection)
• Improve processes, SOPs and quality initiatives

Required profile

• Advanced degree (M.D., MS or PhD) in a scientific or bioengineering field, with 8-12 years in clinical affairs or research project management and at least 4 years managing people
• Premarket and/or postmarket evidence generation experience required; surgical robotics and endoscopic surgery experience highly preferred
• Fluency in English; other European languages preferred; travel up to 30-40% in Europe

Required skills

• Good Clinical Practice, ISO 14155 and EU MDR
• Evidence appraisal and clinical research methodology
• Project management, leadership and cross-functional communication