Exciting opportunity to lead the clinical program for a groundbreaking Point-of-Care (PoC) diagnostic technology for several applications in preparation for the global commercial launch.

As Head of Clinical & Medical Affairs at SpinChip®, you will lead the planning and execution of the clinical program for the SpinChip® diagnostic test. The initial focus is on high sensitivity Troponin I for Acute Myocardial Infarction followed by a host of other applications.

Direct report to Alexis Garras (PhD), VP of Business Development

Your main tasks are:

• Develop the clinical study protocols and associated reporting in line with IVDR 2017/746/EU and the 2022 transition
• Planning, organizing, and monitoring the clinical trials
• Study site selection and establish the legal framework with clinical sites together with VP Business Development
• Drive the implementation of and compliance with the new IVDR regulatory framework among study stakeholders
• Lead communication with regulatory authorities, and ethics committees, together with VP Regulatory Affairs
• Set up Monitoring of the clinical trial programme
• Manage the collaboration with the SpinChip® advisory board
• Data Management (QMS)

Your qualifications include at least 5-10 years of experience in planning and implementing clinical programmes. Experience with medical devices and the regulatory framework is a strong advantage.

You have a thorough knowledge of ICH/GCP, guidelines governing the conduct of clinical studies, IVDR 2017/746/EU and the 2022 transition, and best practices for sample management. It is an advantage if you have outsourcing management experience.

You have a Bachelor/Master/PhD. In Clinical Research or similar.

You are a person with an analytical, qualitative and detail-focused approach. You excels at prioritizing and managing time efficiently. You have critical reasoning skills including the identification and resolution of complex problems. You work autonomously with a minimum of guidance/supervision. You are flexible and work at ease in high performing organizations and international teams. You are structured with good cross-functional communication skills. You thrive by running complex projects to enhance and improve human life. Excellent interpersonal and communication skills and a high level of professionalism and respect, with a willingness to listen.

SpinChip® offers attractive conditions in a varied and exciting collaboration with scientific specialists, who are leading global experts in their respective domains. The office resides in a modern building in Skøyen, Oslo, Norway, where the entire organization works in a shared location from management to manufacturing, research and development. SpinChip® has a strong scientific and ambitious environment med dedicated employees who want to succeed as a team.

Travelling: Limited, but travel related to the planning and implementation of clinical studies will be required. There will be an opportunity to participate in conferences and in travel-related stakeholder management, for example, related to commercial partnerships and cardiac advisory board.

For more details about the job or the company, please contact COO Morten Andersen, Unique Human Capital on M: +45 29 47 30 60 or Research Consultant Emma Josephine Dahl, Unique Human Capital on M: +45 51 43 43 17 or Client Manager Gert Andersen, Unique Human Capital on M: +42 95 08 83. All applications must be in English and are treated confidentially.