Lead, Endoluminal APAC - Clinical Affairs
Core
Lead clinical strategy and execution for endoluminal (bronchoscopy/diagnostic imaging) medical devices across the APAC region, supporting regulatory approval and reimbursement.
Role type
Senior Lead Clinical Affairs Manager (Endoluminal/APAC)
Builds
Clinical study strategies, protocols, and regulatory submissions for minimally invasive surgical devices.
Domain
Healthcare / Medical Devices / Endoluminal Surgery
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical study management, protocol development, regulatory strategy (GCP, ISO14155), budget management, cross-functional collaboration, APAC market knowledge, scientific publication support
Preferred skills
Bronchoscopy/diagnostic imaging device experience, hospital environment familiarity, audit support experience
Technologies
GCP, ISO14155, CRF, SAP
Responsibilities
Develop and execute clinical study strategies for endoluminal products; manage clinical protocols and study documents; oversee study budgets and resources; collaborate with KOLs, sites, and CROs; support regulatory approval and reimbursement strategies; manage team and cross-functional stakeholders.
Seniority
Senior, hands-on IC with strategic leadership