Global Clinical Affairs Lead - Digital and AI (m/f/d) - #2099514

Your Responsibilities The Global Clinical Affairs Lead - Digital and AI (m/f/d) will lead evidence generation activities to support Olympus' Digital/AI product development, regulatory approvals, reimbursement strategies, and commercialization efforts. Reporting to the Global VP of Clinical Affairs, this role collaborates across internal and external teams to ensure high-quality clinical studies and strategies for the Digital and AI business units.

• Develop & Execute Strategy: Lead evidence generation strategies in collaboration with internal and external stakeholders to support product development and business objectives
• Clinical Input: Provide clinical insights to R&D, Business Development, and Digital/AI teams to ensure clinical evidence supports product value
• Study Design & Execution: Oversee the design, execution, and closeout of clinical studies, including protocols, data collection, analysis, and reporting
• Oversight of IIT & CCR: Manage Investigator Initiated Trials and Collaborative Clinical Research initiatives
• Regulatory & Publication Support: Contribute to regulatory submissions and publication strategies
• Cross-Functional Collaboration: Coordinate with teams in Sales, Marketing, R&D, Risk Management, and more to drive clinical success
• Compliance: Ensure studies comply with Olympus policies and global regulatory requirements
• Leadership: Drive Clinical Affairs’ long-term strategy (3-5 years) and contribute to infrastructure improvement through SOPs, best practices, and training
  
  

Your qualification - BA/BS in Life Sciences or related field, advanced degree (MS, PhD, MD) in Life Sciences or related field preferred

• 15+ years in medical device industry, ideally in Clinical Affairs/Operations or Medical Affairs in the biotech space
• Experience with evidence generation in AI studies, particularly CADe/CADx technologies in the GI space
• Proven experience working with global, cross-functional teams and managing people
• Strong knowledge of global regulations for AI software as a medical device
• Ability to think strategically, analyze data, and write scientifically
• Experience managing complex projects with minimal direction
• Excellent communication and relationship-building skills with internal and external stakeholders
• Highly organized, detail-oriented, and capable of leading in a fast-paced environment
• Travel: Up to 15% domestic and international travel, including occasional weekend/evening trips
• Scheduling Flexibility: Flexibility for a global weekly schedule, navigating multiple time zones and working extended hours as needed
  
  

Your benefits - Flexible working hours, remote work possible (up to 60%)

• 30 days of holidays per year
• Modern office and an inspiring working environment
• Employee restaurant with live cooking and healthy food (subsidized)
• Public transport ticket (100 % subsidized) or free parking space
• Company sport groups and an inhouse company gym
• Employee Assistance Program to support your health, mental and emotional well-being
• A comprehensive company pension scheme
• Company medical officer and vaccination offers
• Childcare through our ‘Buttje&Deern’ partner
• Bike leasing
  
  

About Olympus At Olympus, we are committed to Our Purpose of making people’s lives healthier, safer and more fulfilling. As a global medical technology company, we partner with healthcare professionals to provide best-in-class solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating the standard of care in targeted disease states.

For more than 100 years, Olympus has pursued a goal of contributing to society by producing products designed with the purpose of delivering optimal outcomes for its customers around the world.

For more information, visit www.olympus-europa.com and

follow our LinkedIn account: linkedin.com/company/OlympusMedEMEA .

Further information: Your future inclusive workplace awaits

We value the diversity of individuals, perspectives, and lifestyles, and prioritize inclusion and mutual respect. We are committed to fostering a non-discriminatory, inclusive work environment where everyone feels a sense of belonging, in full compliance with legal standards. Empathy and unity are core to our company culture, empowering employees to contribute fully and flourish.

We warmly encourage all who wish to bring their talents to Olympus to apply.