Director, Clinical Affairs (Hybrid or Remote)

Your opportunity

By joining the Kardium team, you can help make a difference in the lives of millions around the world. Kardium is developing a groundbreaking medical device for the minimally-invasive diagnosis and treatment of atrial fibrillation, a heart condition that can cause strokes, heart failure, and other heart-related complications.

Kardium has a fantastic technical team that has developed a product with strong, unique and customer-valued differentiators versus other solutions on the market: The Globe® Pulsed Field System. We have built connections with key opinion leaders who are already using the Globe System and are helping to tell our story.

The purpose of the Director, Clinical Affairs is to oversee and manage all aspects of the clinical portfolio at Kardium, including pre & post-market studies. The Director, Clinical Affairs will guide, develop, and execute long-range clinical trial strategies in the US and world-wide.

Reporting to the VP, Product Management - the Director, Clinical Affairs will partner with teams including Research, Design Engineering, Clinical Engineering, Regulatory Affairs, and Product Management to optimize clinical evidence strategies to meet business objectives. This position will be responsible for working with our Clinical Operations team to plan, implement, execute and manage clinical studies.

We will consider candidates for remote work or hybrid/onsite located in Burnaby, BC.

What You’ll Be Doing

Your responsibilities will include:

• Lead the development of the company's clinical and scientific strategies for FIH, pre-market and post-market studies.
• Direct the development of clinical research strategy, timelines, milestones, project plans/deliverables, budget and resource allocations.
• Monitor the scientific literature to stay up to date on the relevant scientific knowledge and market trends.
• Oversight and development of clinical research infrastructure, including clinical study protocols and case report forms in conjunction with the clinical operations team.
• Directly or indirectly supervise clinical research staff, including consultants and third parties.
• Oversee the timely capture, reporting, and evaluation of adverse events.
• Author Clinical Evaluation Reports for high-risk cardiovascular devices to support regulatory submissions.
• Ensure compliance with corporate (e.g., SOPs) and regulatory requirements (e.g., GCP and US and OUS guidelines).
  
  
  

What You Bring To The Team

Our Kardium team is smart, creative, and passionate about creating cutting-edge medical devices to help improve people’s lives. We work within a collaborative environment based on trust and respect. And we understand that only by working together can we solve the unsolvable.

You are suited to our approach and possess these attributes:

• Advanced degree such as MD, MS or PhD in the scientific/bioengineering field; with 8-12 years of experience in clinical affairs/research project management is preferred.
• At least 3-5 years of management experience, with a proven track record of leadership by example and developing high-performing teams.
• Prior experience in Electrophysiology or Cardiology is highly preferred.
• Excellent ability to interact with physicians and other professionals inside and outside the company.
• Must be able to travel up to 20% to clinical sites; additionally, frequent travel (quarterly) to our headquarters located in Burnaby, BC (if working remotely).
• Possess knowledge of Good Clinical Practice and 21 CFR medical device regulations, ISO 14155, European MDR regulations, and other international regulations.
• Strong understanding and background in clinical trials, study design, and formal ICH/GCP knowledge and training.
  
  
  

Compensation

Kardium has listed the total cash compensation range that we expect to pay applicants for this role, as of the time of this posting. Pay offered will be determined based on numerous relevant business and candidate factors including, for example, education, qualifications, certifications, experience, skills, and business or organizational needs. For candidates with more or less experience than listed above, the pay range will be adjusted.

• $160,000 – 195,000 (CAD Annually)
• Compensation for international candidates will be set based on the relevant market data.
  
  
  

As a permanent employee, you will also participate in Kardium’s stock option plan.

Why work at Kardium

A meaningful career working with a truly innovative technology and an ambitious team, combined with:

• Knowing every day that you are making a difference in people’s lives by helping treat a condition that debilitates millions worldwide
• A great working environment with opportunities to develop your skills and knowledge
• Opportunity to extend your knowledge by interacting with other team members in a multi-disciplinary environment that includes electrical and mechanical engineers, biologists, and specialists in human factors, and clinical and regulatory affairs
• An engaged leadership team who believes in mentoring and growing employees’ careers
• Supportive and fun colleagues with plenty of social events to encourage people connections
• And our employees think we are great too – check out Glassdoor to learn more!
  
  
  

Thanks in advance for your interest in Kardium!