Anteris is a structural heart company delivering clinically superior solutions that help healthcare professionals create life-changing outcomes for patients. We are currently developing the first-in-class biomimetic TAVR valve as a growing and inclusive Medtech team with global office locations in Minneapolis, US; Geneva, Switzerland; and Brisbane and Perth, Australia.
The Clinical Specialist role will play an integral part in successful clinical trial support and execution, advancement of clinical evidence and valve science, and market share adoption of the DurAVR technology. In this role, the Clinical Specialist will be responsible for TAVI clinical trial case support and procedural expertise, and they will play an active role in driving trial enrollment and identifying ongoing educational opportunities to heart team members and the referring community. This individual will work closely in collaboration with Clinical Affairs, Regulatory, R&D, Quality and Marketing to ensure optimal clinical outcomes and complete enrollment as aligned with corporate goals and strategy.
This role may be filled at varying levels, depending on the candidate's previous experience, and will report to the Sr. Director of Therapy Development. This position will require 50-70% travel to support trial-related activities.
Primary Responsibilities:
- Successfully complete internal training program, including competency with CT and echo imaging, internal IFU, best practices, marketing messaging, clinical evidence, and competitive knowledge.
- Interface with customers, demonstrating expertise and key competencies in all technical aspects of TAVI clinical case support, training & education, customer service and communication skills.
- Demonstrate competency and expertise in all procedural aspects, including valve loading & preparation and device delivery and implantation according to established best practices, complication mitigation and troubleshooting techniques for DurAVR THV.
- Demonstrate proficiency and understanding of all aspects of the approved DurAVR clinical trial protocol, including inclusion & exclusion criteria, and accuracy in obtaining any required imaging and pre & post procedural data.
- Demonstrate proficiency in pre-case planning, CT analysis and pre & post procedure recommendations to ensure optimal clinical outcomes.
- In-depth knowledge and understanding of existing DurAVR clinical data as well as all competitive TAVI data.
- Support the Clinical & Regulatory Operations team, assisting with site communications, data compliance activity, screening review efficiency and site submission efficiency.
- Attend clinical cases, supporting the heart team with device prep and loading of the DurAVR valve in each assigned case.
- Provision of education and guidance to physicians and site staff in identifying appropriate study patients and assist site in ensuring complete patient screening and enrollment information.
- Track all patient pathway screening process activity, routinely providing metrics per site on screening and progress of enrollment.
- Assist customers with inventory management, including ordering, shelf stock and ordering.
- Identify operational improvement opportunities at the site level and recommend programs for enrollment acceleration, improved efficiency, and appropriate expanded therapy advancement tools and strategies.
- Provide feedback and insights from clinicians on product, procedural, or clinical development activities and any performance-related issues to device to design and improvements.
- Provide feedback to cross-functional teams on market intelligence, physician preferences and clinical evidence dissemination.
- Uphold the company AORTIC values: Accountability, Objectivity, Respect, Teamwork, Integrity, and Courage.
Required Skills, Knowledge, Experience & Qualifications:
- Bachelor of Science in health sciences, nursing, or life sciences.
- A minimum of three years of medical device support and experience working in the sterile environment of a cath lab or operating room required.
- Previous Structural Heart experience is required; TAVR strongly desired.
Preferred Skills, Knowledge, Experience & Qualifications:
- Clinical expertise specifically in interventional cardiology and TAVI Structural Heart are strongly preferred.
- Outstanding communication, organizational skills, and ability to initiate and manage communication with physicians, research personnel, and internal colleagues.
- Ability to identify and adapt to shifting priorities and competing demands.
- Demonstrates creative resourcefulness, strong problem-solving and decision-making skills.
- Ability to travel 50-70% of the time as needed.
- Independent, self-directed, and confident in leading trainings, providing clinical recommendations and leadership in case support.
- Excellent interpersonal skills, interfacing with multiple constituencies including interventional cardiologists, cath lab staff and site support staff and colleagues.
- Entrepreneurial spirit with a competitive drive and strong work ethic geared toward success.
What We Offer:
- Opportunity to make a significant impact on the healthcare industry by advancing groundbreaking therapies.
- Collaborative and dynamic work environment with a culture of innovation and excellence.
- Competitive compensation package, including salary, performance-based bonuses, and stock options.
- Career development opportunities and a chance to be part of a growing company that values its employees.
Health and Wellness Offerings:
- Medical, Dental, and Vision Offerings
- Flexible Spending Account (FSA)
- 401k + Company Match
- Life, AD&D, Short Term and Long-Term Disability Insurance
- Bonus Plan Eligibility
- Employee Stock Option Plan
- Paid Holidays & Vacation
- Employee Assistance Program
- Inclusive Team Environment
Note: We may require proof of COVID-19 vaccination to comply with health institutions, state, local municipality, and/or travel regulations.
Anteris Technologies recruits, employs, trains, compensates, and promotes regardless of race, religion, color, national origin, sex, disability, age, veteran status, and other protected status as required by applicable law. We have a clear vision: to be a place of belonging for all humans by promoting diversity, multiculturism and inclusion, as a goal and reflection across the organization. Diversity is more than a commitment - it is part of our mission to deliver the best structural heart products on a global scale.