[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.

Responsibilities

• Lead the strategic design and execution of clinical studies (feasibility, pivotal, post-market) for catheter ablation devices and therapies
• Serve as the clinical subject matter expert for electrophysiology, ensuring scientific rigor and clinical relevance across all programs
• Collaborate with R&D, regulatory, marketing, and medical affairs teams to align clinical objectives with business goals
• Develop relationships with global KOLs, investigators, and institutions to support study recruitment and protocol development
• Oversee 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 needed
• Analyze clinical data and provide strategic input on interpretation, reporting, and publication efforts

Skills

• Advanced degree (MD, PhD, or equivalent) preferred; Master's in a related field with extensive experience will be considered
• Minimum 8–10 years of clinical affairs experience in the medical device industry, with a strong emphasis on electrophysiology and catheter ablation
• Demonstrated leadership in planning and executing complex, multi-center clinical trials
• Proven track record of successful regulatory interactions and submissions (FDA, EMA, etc.)
• Deep understanding of electrophysiology clinical workflows, unmet needs, and physician decision-making
• Exceptional communication, leadership, and cross-functional collaboration skills
• Willingness to travel domestically and internationally (up to 20%)
• Clinical background in cardiology or electrophysiology preferred (e.g., former EP clinician or clinical specialist)

Benefits

• 5% 401k contribution
• Participate in Kardium’s stock option plan
• Base salary, plus a contribution to a Registered Retirement Savings plans (RRSP) to help support your financial goals
• Comprehensive medical & dental coverage – for all permanent employees – effective as of Day 1, with no waiting period
• Work-day flexibility – additionally, we provide 3 personal days per year
• Support – for you (and your dependents) overall well-being
• Career progression and learning support
• Professional membership support

Company Overview