VP Clinical Affairs – Cardiovascular & Neurovascular US

Key responsibilities: Own clinical strategy and trial design for an active IDE pivotal program Partner directly with regulatory affairs on the path to PMABuild, lead and scale the clinical affairs function as headcount grows Lead relationships with CROs, principal investigators and KOLs across trial sites Sit on the leadership team, partnering with CEO, CMO and R&D on product and trial-design decisions Own clinical data strategy and reporting in partnership with biostatistics Support clinical sections of FDA submissions Represent the company externally with investors, KOLs and at scientific/clinical conferences Ideal background: Senior clinical affairs leadership experience within cardiovascular or neurovascular medical devices Proven track record running IDE trials through to PMAStrong understanding of the US Class III clinical pathway Experience building and managing a clinical affairs team, not just running trials individually Strong investigator/KOL relationships and clinical network Entrepreneurial, hands-on leadership style with the ability to operate in a growth environment This is an opportunity to join an organization with significant growth ambitions and have a direct impact on its clinical strategy and path to approval.📩 Interested? Send me a message directly or connect with me for a confidential conversation.