Sr. Director, Clinical Affairs

Supira Medical, a clinical-stage Shifamed Portfolio Company, is developing a low-profile, high continuous flow percutaneous ventricular assist device (pVAD) to provide temporary mechanical circulatory support in high risk percutaneous coronary interventional (HRPCI) procedures as well as patients suffering from cardiogenic shock. To learn more about Supira Medical, please visit www.supiramedical.com. ABOUT SHIFAMED Founded in 2009 by serial entrepreneur Amr Salahieh, Shifamed LLC is a privately held medical device innovation hub focused on the development of novel medical products to address clinical needs in the rapidly evolving fields of cardiology and ophthalmology. Description:

The Senior Director, Clinical Affairs is a hands-on leadership role responsible for driving the execution and overall success of Supira Medical's IDE pivotal clinical trial. This individual will own the operational, strategic, and cross-functional execution of the trial — from site activation through database lock — and will serve as the primary internal owner ensuring the study is executed on time, within budget, in full compliance with FDA and ISO 14155 requirements, and with the data integrity needed to support a successful PMA submission. This role partners closely with the R&D, Quality, Regulatory Affairs, and Marketing, and manages relationships with CROs, clinical sites, and key opinion leaders (KOLs).

Responsibilities, Skills & Hands-On Experience: * Clinical Trial Execution: Own end-to-end execution of the company's IDE pivotal clinical trial, including site activation, enrollment, monitoring, data collection, and database lock, ensuring the study stays on timeline and within budget. Develop and propose strategies to address study issues. * Protocol, Study Design, & Trial Documentation: Partner cross-functionally to finalize/amend the clinical protocol, study Charters, project plans, statistical analysis plan, and informed consent documents; l