Director, Clinical Affairs (Hybrid or Remote)

at  Kardium Inc

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 the most common heart rhythm disorder, atrial fibrillation – which can cause stroke, heart failure, and other heart-related complications.
Kardium’s mission is to deliver the best treatment for atrial fibrillation. To achieve this, we have developed The Globe® Pulsed Field System – we have a fantastic technical team that has developed a product with strong, unique, and customer-valued differentiators versus other solutions on the market. We have built connections with key opinion leaders who are already using the Globe System and are helping to tell our story.
We have now completed our pivotal clinical study and our focus is on regulatory approvals and commercial launch. This is an exciting and significant milestone in our journey to bring this ground-breaking technology to patients.
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.
Meaningful work you will be a part of

• 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 will be successful in this role because you 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 (base salary + 5% RRSP or 401K contribution) 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.

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

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

Your Benefits & Well-being
The total cash we’ve listed for this position includes a base salary, plus a contribution to a 401K or 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.
Family building – we provide top up for both maternity leave & adoptive leave. Employees can also enroll in benefit coverage for fertility drug treatment.
Career progression and learning support.
Professional membership support.
Life at Kardium
What makes us a great place to work?
Our Purpose Our People Our Culture
Patient first ​ Brilliant ​ Excellence
Innovation ​ Achievers​ Communication
Quality Trust ​ Decision making ​
At Kardium, we embrace diversity of background, experience, and perspective and we’re committed to inclusion and equity at every level. We encourage applications from all qualified candidates who represent the full diversity of all communities.
We collaborate with Employee Resource Groups (ERGs), as volunteer-led groups who share a common dimension of diversity and come together to provide support, education, and other opportunities across Kardium. Examples of our ERGs include Women ERG, Pride ERG, Race Ethnicity & Cultural Heritage (REACH) ERG, Truth & Reconciliation ERG, Persian Community ERG, Chinese ERG, Barangay Kardium (Filipino) ERG, and Irish ERG.
As part of your application, we encourage you to note if you require an accommodation for the recruitment process (including alternate formats of materials, accessible meeting rooms or other accommodations). There will be an optional section in the application form where you can provide this information to the recruitment team.
And our employees think we are great too – check out Glassdoor to learn more