Senior Specialist, Clinical Development Imaging

Senior Specialist, Clinical Development Imaging TMTT

Patients are at the heart of everything we do. As part of our Medical Affairs team, you’ll foster internal and external collaboration to generate and disseminate evidence-based clinical practices to help impact patient lives and advance the quality of care. Your scientific curiosity and passion for patients will help us grow our reach and develop innovative solutions for people fighting cardiovascular disease.

 Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patient’s unmet clinical needs. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

 How you’ll make an impact:

• We have an exciting opportunity for an exceptional Senior Clinical Imaging professional to join a team that is boldly designing Transcatheter Mitral and Tricuspid Therapies from the ground up. TMTT we are dedicated to solving the complex challenges of mitral and tricuspid disease to transform treatment and significantly improve patients' lives.
• As the Senior Specialist of Clinical Development Imaging, you will perform image analysis and assessment to support new product and procedure development. Develop patient selection criteria, perform retrospective image analysis, provide intra-procedure support for physician training and cutting-edge procedures, and provide input on evolving aspects of the product development process.
• Analyze imaging and or oversee third party image analysis for patient screening and contribute an opinion to the assessment of potential cases for early feasibility and clinical study candidates
• Partner internally and externally in the advancement of next generation imaging technologies
• Represent the clinical development team during complex clinical situations with investigating physicians, hospital staff and clinical research coordinators by providing on-site, real-time guidance during clinical cases 
• Support may include, but not limited to:
• Provide on-site cardiac imaging support and guidance during clinical procedures performed on humans to ensure optimal imaging during the implantation of transcatheter devices. 
• Provide education on aspects of the device/device handling, implantation, and troubleshooting techniques related to equipment, tools, and products required for device implants.
• Document procedural case observations for learning and training updates
• Analyze, summarize, and present clinical screening, procedural, and follow-up imaging (e.g., CT, echo, MRI, angiography) to provide inputs that support new product and procedure development and to support event investigations
• Create training content relevant to imaging procedures and image analysis for health care professionals and or field support teams. Train field support team and or HCPs on cardiac imaging procedures as appropriate
• Work with sites and imaging transfer vendor to answer queries and troubleshoot technical issues

 What you'll need (Required):

• Bachelor's Degree AND 5 years independent echocardiography scanning experience in a clinical setting

OR

• Certification such as: RDCS (Registered Diagnostic Cardiac Sonographer) through ARDMS OR CCI AND 7 years of previous in-hospital and/or industry experience with clinical echocardiography
• Ability to travel up to 50% (domestic & some international) and sit on site in Irvine, California

What else we look for (Preferred):

• Experience in the cardiac cath lab
• Interventional echo imaging experience necessary, particularly with 2D/3D TEE
• Excellent computer skills, including Microsoft Office Suite
• Good imaging analysis software skills (e.g., TomTec, Xcelera, 3Mensio, Vitrea, Circle VI, etc.)
• Substantial knowledge of relevant imaging equipment operation (e.g., 2D or 3D TTE/TEE/ICE, CT, MRI, etc.)
• Significant experience and understanding of principles, theories, and concepts relevant to cardiovascular imaging
• Solid knowledge of GCP (Good Clinical Practices)
• Excellent presentation skills: ability to present material comfortably. team player, networking, communication (written/ verbal) and relationship building skills
• Ability to exercise independent judgment and problem-solving
• Quick learner: ability to come up to speed quickly
•  Work is performed independently on complex projects
• Ability to work positively through confrontation and or conflicting ideas
• Able to effectively guide and instruct other imaging specialists in clinical settings on effective imag