Sr. Director, Clinical Affairs - Endoluminal
Core
Guide and execute long-range clinical evidence strategies for Intuitive's Endoluminal Business Unit, covering first human use, regulatory studies, and post-market evidence generation.
Role type
Senior Director, Clinical Affairs (Medical Device)
Builds
Clinical evidence strategies and plans for new product development and post-market surveillance
Domain
Medical Devices / Endoluminal Technology / Clinical Research
Required skills
Clinical study design, Regulatory strategy (MDR, GCP, ISO 14155), Budget management, Team leadership, Cross-functional collaboration, Strategic planning
Preferred skills
Medical robotics experience, Surgical device background, Operating room settings familiarity, KOL engagement
Technologies
GCP, MDR, ISO 14155, 21 CFR
Responsibilities
Develop clinical and scientific strategies for new products and post-market evidence; Account for development and execution of clinical study plans; Provide strategic guidance to global clinical evidence strategy; Build relationships with regulators, societies, and KOLs; Create KPIs and 3-year evidence plans; Drive implementation of clinical research strategies; Manage year-over-year program budgets; Provide leadership to the Clinical Affairs team; Ensure compliance with regulatory requirements; Review and approve key clinical documents.
Seniority
Senior Director, Strategic Leadership & Management