Field Clinical Specialist

The Opportunity

This position works in the Structural Heart division. Our business purpose is to restore health and improve quality of life by designing and providing device and management solutions for treating structural heart disease.

As the Field Clinical Specialist, along with your leadership team you will plan and manage multiple or complex/partnership cost center or Clinical Development Program(s) across all functional areas, within budget and timelines. Represent clinical development function at Advisories, interactions with Regulatory Agencies and for evaluation of business opportunities including due diligence. Actively participate in the conduct of clinical trials with participating staff and advisors, to determine appropriate patient selection, surgical planning, procedural detail, case summaries and other clinical data.

What You'll Work On

• Responsible for financial oversight of contracts and expenses at a specified level, including budgetary management for cost centers or clinical programs. This encompasses setting strategic direction, creating and managing budgets, prioritizing initiatives, overseeing staff development, and ensuring accurate study budgeting, contract development and execution, as well as payment processing and expenditure tracking
• Effectively communicate clinical, product, and market information through strategic meetings, presentations, and technical discussions—presenting recommendations to leadership, supporting product marketing strategies, and linking data outcomes to key messaging.
• Participate in strategy development and execution for specified clinical area.
• Coordinate cross-functional teams to drive clinical program progress, ensuring timely achievement of strategic goals and milestones, while serving as the primary clinical resource for procedural support, troubleshooting, and in-service education on company products.
• Anticipate potential problems within a clinical program and create contingency plans accordingly. Elevate potential changes in regulatory or clinical environment to leadership.
• Critical review of vendor proposals and contracts to include CRO agreements to ensure program success.
• Program/development strategy/direct line management and research matrix management.
• Clinical operational representative for worldwide project team.
• Engage in daily collaboration with directors, project managers, and cross-functional teams—including finance—while coordinating logistics and providing technical support to site care teams as needed for case coverage.
• Manages internal organization/department within larger Clinical organization in a cross-functional environment.
• Train Surgeons, Interventional Cardiologists, catheter lab staff and ancillary personnel on the use of Structural Heart products and provide technical support to physicians during procedures.
• Ensures compliance with protocol and all regulatory policies, procedures and/or guidelines during clinical studies by training/guidance of investigators/study coordinators.
• Apply advanced theory understanding and advanced experience regarding technical subject matter to process and interpret Echo and CT studies of potential patient-subjects seeking to participate in trial.
• Establish policy and ensures adherence to applicable ethical regulatory and clinical standards by participating in the creation, review, and approval of departmental operating procedures, code of ethics, and mission statement.
• 80% travel may be required

Required Qualifications

• BS/BA or equivalent related work experience required
• Strong understanding of heart failure and Cardiac hemodynamics
• Minimum of 6-8 years of related work experience required
• Experience with Imaging analysis with CT CAD software and Echo analysis.
• Strong clinical background and Interventional/surgical cardiac procedural experience
• Experience with Sterile Technique and Aseptic Technique
• Ability to wear Lead Apron for interventional procedures for extended periods of time
• Experience and understanding of Hemodynamics and hemodynamic monitoring devices
• Working understanding of Heart failure and standards of care supporting Heart Failure patients
• Ability to travel up to 80% of the time, including some international travel
• Clean DMV record

Preferred Qualifications

• Degree in life sciences or medical training (RN, Perfusion, PA etc.) preferred
• Medical industry preferred
• Strong clinical orientation, experience with products for use in interventional cardiology and cardiac surgery, familiarity with echo cardiography and other indirect imaging, also strongly preferred