Head of Clinical Affairs

Job Summary

A company is looking for a Head of Clinical Affairs (remote - US) to set up global study operations for a start-up medical device company focusing on Cardiology.

Key Responsibilities:

• Lead and strategize clinical operations, overseeing US and EU trials and regulations
• Build and manage global teams for the pivotal trial across the EU and US
• Utilize strong FDA experience to lead product discussions with the FDA

Required Qualifications:

• Demonstrable high-level strategic experience in clinical affairs or leading departments
• Extensive experience in US and EU trial management and regulations
• Excellent KOL network across both continents
• Strong FDA experience, including leading product discussions
• Medical device experience within Cardiology