Clinical Project LeaderEU-Japan Corridor

This is a pioneer role. You will be the first Eclevar clinical hire in Japan, responsible for building our operations from the ground up: managing Japanese clients, establishing our KOL network, and acting as the in-country bridge between Japanese real-world clinical evidence and European regulatory frameworks.

• ›Manage Japanese client accounts end-to-end: protocol review, site management, regulatory submission support.
• ›Coordinate PMDA pre-submission consultations and clinical data bridging gap analyses.
• ›Ensure Japanese GCP (Ordinance 169) compliance on all studies.
• ›Build relationships with Japan's leading cardiovascular KOLs (OCEAN-TAVI, NCVC, PCR Tokyo Valves).
• ›Identify potential co-investigators for the EU-Japan white paper.
• ›Cultivate relationships with imaging core lab directors.
• ›Serve as the Japan-side regulatory expert for the PMDA-EU MDR data bridging service.
• ›Conduct regulatory feasibility assessments for Japanese manufacturers.
• ›Translate PMDA guidance into EU MDR-compatible formats.
• ›Recruit and manage a Japan clinical operations team as the corridor grows.
• ›Define Japan SOPs aligned with Eclevar's EU regulatory framework.
• ›Act as the internal voice of Japan for all EU clinical investigations.

Build the Japan clinical team from scratch. Rare chance to shape a new CRO corridor with full autonomy.

Send your CV/Resume and a short cover note explaining your PMDA experience and existing KOL network.