Director of Clinical Affairs

Director of Clinical Affairs

A great opportunity to lead the planning and execution of critical clinical activities and to provide overall program leadership and management in a super-interesting company!

Responsibilities:

• Develop and implement strategic plans for the clinical affairs in alignment with the overall company goals
• Overall responsibility for conducting regulated in vitro diagnostic (IVD) clinical trials in Europe and in the US
• Lead and manage cross-functional teams in the planning and execution of clinical trials

Required Qualification:

• MSc or higher degree in a scientific discipline
• At least 7 years of experience in medical device or IVD clinical affairs with broad management experience managing trials and vendors
• Extensive experience managing clinical programs, CROs, budgets, and timelines, including hands on experience in the performance and execution of key clinical trial activities (writing study protocols, contracting and managing clinical sites, managing recruitment challenges, ensuring adequate data collection and recording, analyzing and reporting study data etc.)
• Team leadership experience
• Knowledge of Notified Bodies, CE/IVDD/IVDR and FDA requirements and regulations
• Ability and willingness to travel up to 20% of the time
• Fluent English

Offices are located at the Shfela area (hybrid)