At Powerful Medical, we are building a global life-saving technology. Our certified product diagnoses cardiovascular diseases (#1 cause of death globally) by scanning ECGs using AI and machine learning. We’re currently cooperating with several leading healthcare providers within the US and the EU and are backed by US, European, and Israeli VCs.

As the Head of Clinical Research at Powerful Medical, you will play a key role in driving our innovative medical technologies forward. In this strategic and hands-on position, you will lead all clinical research activities, from design and planning to execution and management of clinical studies. You’ll ensure our trials meet top regulatory standards in both the US and Europe while exploring new approaches that enhance research quality. Working closely with cross-functional teams, you’ll help bring breakthrough medical solutions to market, ensuring that clinical trials are conducted efficiently, ethically, and in alignment with the company’s strategic goals. This is an opportunity to lead, innovate, and make a significant impact in healthcare.

Your role

• Leadership and Strategy: Create and lead the strategy for the clinical research team, align with business objectives, and drive innovation and excellence
• Clinical Trial Management: Lead the planning and execution of clinical trials, ensuring quality, budget, and timeline adherence, and manage site selection
• Regulatory Compliance: Ensure clinical trials follow US and EU regulations (FDA, EMA) and maintain up-to-date knowledge of regulatory requirements
• Data Management and Reporting: Oversee clinical data collection, analysis, and reporting, and provide strategic recommendations based on trial results
• Post-Market Clinical Follow-Up: Implement strategies to monitor product safety and performance post-market, ensuring compliance with EU MDR
• Cross-functional Collaboration: Work with various departments (R&D, regulatory, medical) to integrate clinical research into product development
• Team Development: Build and manage a high-performing clinical research team, fostering growth and development

Your profile

• MD, PhD, or equivalent in a relevant scientific or medical field
• 5+ years of experience in clinical research within the medical device industry, ideally Software as Medical Device (SaMD)
• Proven track record of successfully managing all phases of clinical trials, from early-stage to post-marketing studies, in both the US and EU
• Extensive knowledge of regulatory requirements and guidelines (e.g., FDA, EMA, ICH-GCP)
• You have a commercial focus in the application of regulatory requirements
• Excellent project management and communication skills to coordinate regulatory agencies and consultants
• Display, encourage, and inspire a culture of excellence across our entire organization
• Experience with AI/ML-based medical devices and cardiology medical devices is preferable