[Remote] Director, Clinical Affairs

Note: The job is a remote job and is open to candidates in USA. Kardium Inc. is a company dedicated to improving the lives of patients with atrial fibrillation through innovative medical devices. They are seeking a Director of Clinical Affairs to lead global clinical studies in electrophysiology and catheter ablation, ensuring alignment with product strategy and regulatory pathways.ResponsibilitiesLead the strategic design and execution of clinical studies (feasibility, pivotal, post-market) for catheter ablation devices and therapiesServe as the clinical subject matter expert for electrophysiology, ensuring scientific rigor and clinical relevance across all programsCollaborate with R&D, regulatory, marketing, and medical affairs teams to align clinical objectives with business goalsDevelop relationships with global KOLs, investigators, and institutions to support study recruitment and protocol developmentOversee CROs, clinical sites, and internal teams to ensure adherence to timelines, budgets, and regulatory compliance (GCP, FDA, EU MDR)Support regulatory submissions (IDE, PMA, CE Mark) and interface with regulatory agencies as neededAnalyze clinical data and provide strategic input on interpretation, reporting, and publication effortsSkillsAdvanced degree (MD, PhD, or equivalent) preferred; Master's in a related field with extensive experience will be consideredMinimum 8–10 years of clinical affairs experience in the medical device industry, with a strong emphasis on electrophysiology and catheter ablationDemonstrated leadership in planning and executing complex, multi-center clinical trialsProven track record of successful regulatory interactions and submissions (FDA, EMA, etc.)Deep understanding of electrophysiology clinical workflows, unmet needs, and physician decision-makingExceptional communication, leadership, and cross-functional collaboration skillsWillingness to travel domestically and internationally (up to 20%)Clinical background in cardiology or electrophysiology preferred (e.g., former EP clinician or clinical specialist)Benefits5% 401k contributionParticipate in Kardium’s stock option planBase salary, plus a contribution to a Registered Retirement Savings plans (RRSP) to help support your financial goalsComprehensive medical & dental coverage – for all permanent employees – effective as of Day 1, with no waiting periodWork-day flexibility – additionally, we provide 3 personal days per yearSupport – for you (and your dependents) overall well-beingCareer progression and learning supportProfessional membership supportCompany OverviewKardium has developed the Globe System - a revolutionary medical device for the diagnosis and treatment of atrial fibrillation. . It was founded in 2007, and is headquartered in Burnaby, British Columbia, CAN, with a workforce of 501-1000 employees. Its website is http://kardium.com.