Director Clinical Affairs

About the role

Intuitive, a leader in robotic-assisted surgery, is looking for a Director Clinical Affairs in Aubonne. The role develops and executes short- and long-term clinical study strategies and plans to support premarket and postmarket clinical evidence for assigned Intuitive products and European markets. It works in a global matrix with regional and country leaders, Marketing, Medical Affairs, Market Access, Regulatory Affairs, Finance, Legal and Global Public Affairs.

Key responsibilities

• Lead teams in developing and coordinating clinical evidence generation and dissemination, including outcomes research studies, manuscripts, registries, collaborative studies, society collaborations and investigator-initiated studies
• Translate strategy and technical content into a clear evidence roadmap and set priorities balancing short- and long-term needs
• Oversee European clinical research activities, including company-sponsored, collaborative and investigator-initiated studies, with minimal supervision
• Build relationships with KOLs, hospitals and medical/surgical societies
• Review and approve key documents such as Clinical Investigation Plans, Clinical Study Reports and PMCF plans and reports
• Hire, coach and develop the clinical affairs staff and lead the broader Clinical Affairs organization
• Ensure compliance with corporate and regulatory requirements (GCP, EU MDR, US FDA, data protection) and improve processes and quality

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 of people management
• Premarket and/or postmarket evidence generation experience required; surgical robotics and endoscopic surgery experience highly preferred
• Fluency in English; other European languages preferred
• Willingness to travel up to 30-40%, mainly in Europe

Required skills

• Good working knowledge of GCP, ISO 14155 and EU MDR
• Strong scientific acumen in evidence appraisal and clinical research methods
• Leadership, project management and communication skills