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

OLYMPUS EUROPA SE & CO. KG; Hamburg; Hybrid; EUR 80.000 - 120.000; Vollzeit

Zusammenfassung

An established industry player is seeking a Global Clinical Affairs Lead for Digital and AI initiatives. This pivotal role involves leading evidence generation strategies, overseeing clinical studies, and collaborating with cross-functional teams to ensure compliance and success in product development. With a focus on innovative AI technologies, the position offers a dynamic environment where your expertise will drive significant contributions to healthcare advancements. If you are passionate about improving patient outcomes and thrive in a fast-paced setting, this opportunity is perfect for you.

Leistungen

Flexible working hours

30 days of holidays

Modern office environment

Employee restaurant

Public transport ticket

In-house gym

Employee Assistance Program

Company pension scheme

Medical officer

Bike leasing

Qualifikationen

• 15+ years in medical device industry, ideally in Clinical Affairs.
• Experience with evidence generation in AI studies.

Aufgaben

• Lead evidence generation strategies for Digital/AI product development.
• Oversee design and execution of clinical studies.

Kenntnisse

Strategic Thinking

Data Analysis

Scientific Writing

Communication Skills

Project Management

Regulatory Knowledge

Relationship Building

Leadership

Ausbildung

BA/BS in Life Sciences

MS/PhD/MD in Life Sciences

Jobbeschreibung

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

Olympus Europa SE & Co. KG (OEKG) Medical & Scientific Affairs

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.

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.

Your Qualification

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.

Your 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 in-house 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.

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.