Your Mission
The Role in Japan
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.
Clinical Operations
- 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.
KOL Relationships
- 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.
EU–Japan Corridor
- 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.
Team Building
- 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.
Profile
What we are looking for
Required Qualifications
- Minimum 5 years of clinical research experience in medical devices.
- Solid understanding of PMDA regulatory pathways (Shonin, Ninsho).
- Working knowledge of EU MDR 2017/745 (clinical evaluation, PMCF).
- Fluent Japanese (native or equivalent) and professional English.
- Demonstrated ability to manage client relationships.
Strong Assets
- Prior experience at a PMDA-registered CRO (Cobridge, CMIC, etc.).
- Existing relationships with Japanese cardiovascular KOLs.
- Experience designing dual-purpose studies (ISO 14155 & Japan GCP).
- MD, PharmD, or PhD in a relevant scientific discipline.
Benefits
Why join Eclevar?
Pioneer Opportunity
Build the Japan clinical team from scratch. Rare chance to shape a new CRO corridor with full autonomy.
EU–Japan Bridge
Work at the intersection of two of the world's most sophisticated regulatory frameworks.
Compensation
¥8,736,000 – ¥13,104,000
+ Performance bonus & Conference travel budget (EuroPCR, TCT, PCR Tokyo).
Ready to build the EU–Japan bridge?
Send your CV/Resume and a short cover note explaining your PMDA experience and existing KOL network.
Apply via Email →
