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Senior Vice President of Clinical Operations
2 months ago
Position Overview:
The Mullings Group is seeking a Vice President of Clinical Affairs specializing in heart failure to spearhead the development of an innovative Interatrial shunt paired with a cutting-edge remote patient monitoring system.
Company Vision:
This organization is dedicated to advancing solutions for heart failure management. Recently, they secured $33.5 million in Series C funding aimed at enhancing product development and initiating clinical applications of their adjustable interatrial shunt, which incorporates integrated bi-atrial pressure monitoring.
Product Features:
The device boasts a shunt with a flow channel featuring adaptable geometry, allowing for post-implantation adjustments in size through a proprietary induction catheter. Additionally, the implantable device is equipped with integrated sensors that capture pressure readings from both the left and right atria multiple times daily, without necessitating patient interaction.
Clinical Insights:
These frequent readings empower healthcare providers with a comprehensive understanding of a patient's hemodynamic status, enhancing shunt therapy and facilitating informed medical management. Heart failure is a progressive condition affecting approximately 6.5 million individuals in the United States and an estimated 26 million worldwide.
Key Qualifications:
- Extensive executive-level experience in clinical affairs; regulatory affairs or quality assurance experience is advantageous.
- Proven track record with first-in-human trials through to larger studies for regulatory approval in the US and/or EU; leadership experience across all phases is highly desirable.
- Cardiovascular expertise at a senior level, particularly in heart failure; experience in interventional cardiology or heart failure is strongly preferred.
- Background primarily in medical devices.
- Exceptional interpersonal skills with a proven ability to engage with global medical key opinion leaders.
- Willingness to travel for conferences and case studies, including international travel.
- Experience with class III implantable devices or complex class II products is preferred.