Clinical Evidence Lead

Clinical Evidence Lead Join BK Medical and be part of our small but growing team in Clinical Development. Together with Clinical Application and Clinical Outcomes, Clinical Development is one of the three specialized teams that make up the Department of Clinical Value Proposition and Evidence. This is your opportunity to become part of an innovative team, where your work has a real impact on people’s lives around the world.
Clinical Development consist of a smaller newly established team of highly experienced Clinical Scientists and Clinical Evidence Leads. Our main responsibilities are to drive the clinical strategies to ensure timely execution on clinical deliverables to support regulatory submissions and commercial strategies. We are an international team who value cultural and personal diversity in an informal, friendly, and respectful atmosphere. We strive to apply data driven methodologies and evidence-based decision making in our daily work. At the same time, we value a balanced and pragmatic approach to problem solving in a fast-growing company.

Key responsibilities for our new Clinical Evidence Lead

• Leads the clinical development and clinical data strategy across application areas
• Leads the wording, substantiation, and documentation of clinical claims for regulatory compliance and commercial utilization
• Contributes to the clinical evidence activities in development projects and gives input to PMCF
• Defines clinical milestones and project deliverables
• Supports clinical evaluation activities and documentation
• Supports post market clinical activities including PMCF
• Collaborates in the development of regulatory strategies for market approvals
• Provides ad hoc support and guidance on activities and documentation requiring clinical competences

As our new Clinical Evidence Lead, your typical tasks will include

• Ensure the development and implementation of clinical evidence strategies
• Facilitate the understanding of clinical deliverables in the organization
• Develop the documentation of clinical claims and their substantiation
• Support Post Market Clinical Follow-up activities
• Establish and maintain the Clinical Development Plan
• Perform literature searches/reviews to maintain surveillance of published literature and clinical results

Your professional background
You bring a BA. or higher degree in the Life Sciences or related disciplines with:

• A minimum of 5 years direct experience in clinical development of medical devices
• Demonstrated expert knowledge and comprehensive understanding of applicable GCP, ICH guidelines & FDA, MDR and relevant applicable international guidelines and regulations
• Excellent interpersonal, written/verbal communication & organizational skills
• Strong program management and financial skills
• Fluent verbal and written English language

Our mission at BK Medical is to change the standard of care in surgical interventions with real-time visual guidance. You will become part of a true innovator in the MedTech industry with 800 colleagues in Denmark, the United States, and other locations around the world. Now, we are advancing our mission as part of GE HealthCare. This puts us in a position where we can think even bigger and unlock new opportunities for us, surgeons, and their patients. It’s a great time to join us!

GE Healthcare is a leading global medical technology and digital solutions innovator. The mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.

We are an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

BK Medical’s European Headquarters are in Herlev, Denmark, with more than 300 employees. The work atmosphere is casual, and our organizational structure is flat. We have a good staff canteen focusing on health and variety, private health insurance and pension plans, as well as social events and several staff clubs.

We look forward to receiving your application, in which you describe:

• what your motivation is for becoming part of our Clinical Development team and
• which of your experiences and skills you will particularly contribute.