Head of Clinical Research
October 19
Description
• Create and lead the strategy for the clinical research team, align with business objectives, and drive innovation and excellence • Lead the planning and execution of clinical trials, ensuring quality, budget, and timeline adherence, and manage site selection • Ensure clinical trials follow US and EU regulations (FDA, EMA) and maintain up-to-date knowledge of regulatory requirements • Oversee clinical data collection, analysis, and reporting, and provide strategic recommendations based on trial results • Implement strategies to monitor product safety and performance post-market, ensuring compliance with EU MDR • Work with various departments (R&D, regulatory, medical) to integrate clinical research into product development • Build and manage a high-performing clinical research team, fostering growth and development
Requirements
• 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
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