Ihre Aufgaben

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

Ihre Qualifikationen

- 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

Ihre Vorteile

- 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

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