Global Director, Endoluminal Clinical Affairs

Intuitive; Sunnyvale (CA); On-site; USD 240,000 - 360,000; Full time

Job summary

Intuitive is seeking a Director of Clinical Affairs for Endoluminal to lead long-range clinical trial strategies, including first human use and post‑market evidence generation. The role requires global collaboration with R&D, Regulatory, and GPA to optimize evidence plans and regulatory submissions, while guiding a cross‑functional team across geographies.

The position entails setting up 3‑year evidence plans, managing budgets, and ensuring GCP/ISO compliance, with travel up to 30–40%.

Qualifications

• Advanced degree such as MD, MS or PhD in scientific/bioengineering with 8–12 years in clinical affairs.
• Management experience of 3–5 years.
• IDE, pre‑market and/or post‑market evidence generation experience.
• Strong knowledge of GCP, 21 CFR, ISO 14155, MDR and related regs.
• Leadership and collaboration across cross‑functional teams.
• Willingness to travel 30–40%.

Responsibilities

• Lead development of clinical and scientific strategies for Endoluminal technology.
• Steer clinical plans and trials to regulatory compliance (MDR, GCP, ISO 14155).
• Provide strategic guidance for global clinical evidence and reimbursement planning.
• Collaborate with regulatory, R&D, and commercial teams across a global matrix.
• Translate strategic content into a clear evidence roadmap with KPIs and 3-year plans.
• Oversee budgets and coach the Clinical Affairs team toward goals.

Skills

Leadership

Clinical trials

Regulatory knowledge

Project management

Stakeholder communication

Education

MD/MS/PhD in scientific/bioengineering

Job description

Intuitive is seeking a Director of Clinical Affairs for Endoluminal to lead long-range clinical trial strategies, including first human use and post‑market evidence generation. The role requires global collaboration with R&D, Regulatory, and GPA to optimize evidence plans and regulatory submissions, while guiding a cross‑functional team across geographies.

The position entails setting up 3‑year evidence plans, managing budgets, and ensuring GCP/ISO compliance, with travel up to 30–40%.