Director, Clinical Affairs (Burnaby)

Your opportunity

By joining the Kardium team, you can help make a difference in the lives of millions around the world. We have developed a ground-breaking medical device for the diagnosis and treatment of atrial fibrillation, the most common heart rhythm disorder, which can cause stroke, heart failure, and other complications. Kardium’s mission is to deliver the best treatment for atrial fibrillation. We have developed the Globe® Pulsed Field System – a revolutionary solution designed by our technical team. With FDA approval, we have officially begun the commercial launch of the Globe® Pulsed Field System, bringing this life-changing technology to patients.

Hybrid work arrangement, located in Burnaby, BC. This is a pivotal and exciting time in our journey.

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.

Qualifications

• 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 robust 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).

Compensation

• Annual total cash compensation $180,000–$230,000 CAD (includes base salary and 5% RRSP contribution).
• Permanent employee; participation in Kardium’s stock option plan.

Benefits & Well‑being

• Comprehensive medical and dental coverage effective from Day1, with no waiting period.
• Workday flexibility and 3 personal days per year.
• Support for overall well‑being for you and your dependents.
• Career progression and learning support.
• Professional membership support.
• Family building: top up for maternity and adoptive leave, and coverage for fertility drug treatment.