Senior Clinical Research Scientist

Anteris® Technologies is a global structural heart company dedicated to revolutionizing cardiac care. With offices in Minneapolis, MN, US; Geneva, Switzerland; and Brisbane and Perth, Australia, we have a growing and inclusive team. Our mission is to forge new frontiers in cardiac care by pioneering science-driven and measurable advancements to restore heart valve patients to healthy function. Transcatheter Aortic Valve Replacement (TAVR) technologies were originally designed for older, high-risk patients. Today, younger, more active patients need a better solution that will not just open and close but restore healthy heart function. We seek to restore healthy blood flow patterns by creating the world’s first biomimetic TAVR valve, DurAVR® THV. This cutting-edge valve, incorporating our proprietary ADAPT® anti-calcification technology, is designed to mimic the natural function of a healthy heart valve. The  Senior Clinical Research Scientist  will provide scientific, clinical, and operational expertise to support Anteris’ global clinical studies and ensure scientific objectives are achieved. This individual will work cross-functionally on the design, execution, monitoring, interpretation, and communication of clinical trial data to help advance patient outcomes through Anteris’ breakthrough structural heart technologies.   This position reports to the Senior Manager, Clinical Research, and collaborates closely with the broader clinical and cross-functional teams to support ongoing clinical studies, clinical documentation, and the dissemination of clinical data through publications and congress activities. This is a highly visible role with the opportunity to make a significant impact at Anteris Technologies.   At Anteris Technologies, you’ll join a mission-driven team dedicated to improving the lives of patients with aortic stenosis through breakthrough structural heart technologies while helping shape the future of structural heart care.     Primary Duties and Responsibilities   Represent Anteris as an industry leader within scientific, clinical research, and industry organizations   Serve as a Scientific Lead and Subject Matter Expert for Anteris-sponsored clinical studies   Partner cross-functionally to support the scientific objectives of Anteris-sponsored clinical studies and advance the company’s mission as a science-driven organization   Lead execution of the subject selection process to ensure accurate and timely review of subject eligibility criteria, with oversight from clinical leadership   Oversee external vendor performance and drive effective cross-functional collaboration   Contribute to clinical trial design, protocol development, protocol revisions, and reports supporting regulatory submissions, with guidance from clinical leadership   Participate in publication planning activities in collaboration with cross-functional stakeholders   Support charter development for clinical studies in partnership with external vendors and study leadership, with oversight from clinical leadership   Perform data analysis and interpretation in collaboration with external biostatisticians and internal data management teams   Deliver timely study updates to clinical and cross-functional leadership through clear, well-structured presentations and data summaries   Develop, maintain, and review clinical study reports and related documentation   Contribute to root cause analyses, corrective and preventive actions, and effectiveness monitoring, with oversight from clinical leadership   Collaborate with internal and external stakeholders, including study sites, vendors, and committees, to support clinical trial objectives and appropriately escalate issues when needed   Build and maintain strong relationships with study investigators and key opinion leaders   Contribute to Medical Legal Review (MLR) activities as a clinical subject matter expert for external data releases, ensuring scientific accuracy and appropriate clinical interpretation prior to publication or disclosure   Assist in compiling clinical documentation and data for regulatory submissions   Provide cross-functional clinical training and education support       Required Education & Experience   Advanced degree in Life Sciences required; MD or PhD preferred   5+ years of Clinical Science or Clinical Research experience within cardiology, cardiovascular, or medical device environments   Experience contributing scientifically to medical device clinical trials   Proficiency in medical terminology and medical writing, including experience working within ICMJE guidelines   Knowledge of healthcare ethics and compliance regulations   Strong work ethic, self-motivation, collaboration skills, and excellent written and verbal English communication skills     Preferred Skills, Knowledge, Experience & Qualifications:   TAVR clinical research experience strongly preferred   Extensive clinical or scientific experience with advanced training in research, study design, and statistics (MSN, PhD, MS, or equivalent)   Experience with imaging modalities, including echocardiography, CT, and CMR interpretation   Experience supporting international, multi-center, randomized clinical trials   Experience with statistical software programs such as Matlab, SPSS, or SAS is a strong plus   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 Plans   Flexible Spending Account (FSA)   401k + Company Match   Life,