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Global Clinical Affairs Lead - Digital and AI (m/f/d), Hamburg
Client: Olympus
Location: Hamburg, Germany
Job Category: Other
EU work permit required: Yes
Job Reference: b3d420df8b02
Job Views: 2
Posted: 27.03.2025
Expiry Date: 11.05.2025
Job Description:
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.
1. Develop & Execute Strategy: Lead evidence generation strategies in collaboration with internal and external stakeholders to support product development and business objectives.
2. Clinical Input: Provide clinical insights to R&D, Business Development, and Digital/AI teams to ensure clinical evidence supports product value.
3. Study Design & Execution: Oversee the design, execution, and closeout of clinical studies, including protocols, data collection, analysis, and reporting.
4. Oversight of IIT & CCR: Manage Investigator Initiated Trials and Collaborative Clinical Research initiatives.
5. Regulatory & Publication Support: Contribute to regulatory submissions and publication strategies.
6. Cross-Functional Collaboration: Coordinate with teams in Sales, Marketing, R&D, Risk Management, and more to drive clinical success.
7. Compliance: Ensure studies comply with Olympus policies and global regulatory requirements.
8. Leadership: Drive Clinical Affairs’ long-term strategy (3-5 years) and contribute to infrastructure improvement through SOPs, best practices, and training.
Minimum Requirements:
1. BA/BS in Life Sciences or related field, advanced degree (MS, PhD, MD) in Life Sciences or related field preferred.
2. 15+ years in medical device industry, ideally in Clinical Affairs/Operations or Medical Affairs in the biotech space.
3. Experience with evidence generation in AI studies, particularly CADe/CADx technologies in the GI space.
4. Proven experience working with global, cross-functional teams and managing people.
5. Strong knowledge of global regulations for AI software as a medical device.
6. Ability to think strategically, analyze data, and write scientifically.
7. Experience managing complex projects with minimal direction.
8. Excellent communication and relationship-building skills with internal and external stakeholders.
9. Highly organized, detail-oriented, and capable of leading in a fast-paced environment.
10. Travel: Up to 15% domestic and international travel, including occasional weekend/evening trips.
11. Scheduling Flexibility: Flexibility for a global weekly schedule, navigating multiple time zones and working extended hours as needed.
Benefits:
1. Flexible working hours, remote work possible (up to 60%).
2. 30 days of holidays per year.
3. Modern office and an inspiring working environment.
4. Employee restaurant with live cooking and healthy food (subsidized).
5. Public transport ticket (100% subsidized) or free parking space.
6. Company sport groups and an inhouse company gym.
7. Employee Assistance Program to support your health, mental and emotional well-being.
8. A comprehensive company pension scheme.
9. Company medical officer and vaccination offers.
10. Childcare through our ‘Buttje&Deern’ partner.
11. Bike leasing.
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