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Head of Clinical Development

Exciting opportunity to lead the Clinical Development team for a groundbreaking epilepsy technology preparing for the global commercial launch

 

As Head of Clinical Development at UNEEG, you will join the clinical affairs team, where the focus is on developing clinical evidence. The products currently span from MDR Class I products to high-risk Class III products for several applications. The portfolio is expected to continue to expand with new technologies.

With direct report to Director Clinical Affairs Lykke Blaabjerg.

Your main tasks are:

  • Set the direction for clinical evaluation of new products as well as changes to existing products taking the risk class into consideration
  • Lead representation and coordination of Clinical Affairs in the cross-functional development project teams
  • Lead and motivate the Clinical Development team to best-in-class performance and develop the appropriate clinical competencies for the team
  • Maintenance of required clinical documentation
  • Assure compliance with medical device regulations, FDA regulations, and other country-specific requirements
  • Ensure all claims are evidence-based in collaboration with the commercial team
  • Ensure SOPs and templates within Clinical Evaluation, Design Validation, and Post Market Surveillance comply with relevant regulatory requirements
  • Support the Clinical Operation team, incl. the development of clinical study-related documentation and executing clinical investigations when needed

Your qualifications are based on experience with clinical evaluation from a similar position within medical devices regulated under MDR / IVDR. You have a track record as a leader managing people to high performance. You are well-versed in design validation, FDA regulations, and practical implementation.

You have a Technical or scientific degree (MSc or Ph.D.) in a health-related field, biology, medical, biomedical engineering, or similar. You are fluent in English and master written English at a professional level.

You are a person with good cross-functional communication skills and thrive by running complex projects. You bring an analytical, qualitative, and detail-focused approach while having critical reasoning skills, including the identification and resolution of complex problems.

You have excellent interpersonal skills showing professionalism and respect – and a willingness to listen. You are a collaborator who appreciates responsibility and working independently when exercising your great planning and organizational skills.

UNEEG offers you a position with the opportunity to lead and develop the Clinical Development area leading to regulatory success and commercial launch. You will get the opportunity for personal growth toward broader organizational strategic impact in a fast-growing organization. The initial focus on EEG related to epilepsy is expected to be followed by other applications and technologies.

Travelling: Limited, approx. 10 days of travel activity per year.

Domicile: UNEEG’s office in Allerød, Denmark.

For more details about the job or the company, please contact Client Manager Gert Vium Andersen, Unique Human Capital on M: +45 42 95 08 83. All applications must be in English and are treated confidentially.

Unique Human Capital A/S
/ /
cvr: 31502705
Jægersborg Alle 4
2920 Charlottenlund
Skelagervej 375E
9000 Aalborg
Christiansgade 30
8000 Aarhus C
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