Senior Manager, Clinical Affairs — Global Trials & Strategy

Intuitive Surgical, Inc.; Sunnyvale (CA); On-site; USD 186,000 - 278,000; Full time

Job summary

Intuitive Surgical, Inc. seeks a Senior Manager of Clinical Affairs to shape clinical strategies and oversee trials for emerging technologies. This role leads a team of study managers and CRAs, coordinating with regulatory, R&D, and PMO to meet regulatory submissions.

The position requires extensive experience in clinical studies, collaboration with KOLs and sites, and strong budgeting and data integrity skills, with travel up to 30–40%.

Qualifications

• Bachelor's or Master's degree in a scientific field or MD/PhD plus 12+ years of experience.
• At least 3–5 years of supervisory experience preferred.
• Extensive experience managing clinical studies through multiple phases.
• Strong cross-functional collaboration and leadership capabilities.
• Experience supporting regulatory submissions and clinical strategy.
• Proven ability to interact with physicians and surgeons, with high attention to detail.

Responsibilities

• Develop clinical study strategies and oversee study execution for emerging technologies.
• Lead a team of clinical study managers and CRAs; manage sites, CROs, and KOLs.
• Ensure regulatory alignment with SOPs and 21 CFR 812 / GCP guidelines.
• Coordinate with Regulatory, R&D, PMO, and other functions to optimize studies.
• Develop and manage study budgets and timelines; ensure high quality data.
• Support publication strategy and dissemination of clinical evidence.
• Travel up to 30–40% as needed to sites and meetings.

Skills

Clinical operations

Project management

Cross-functional leadership

Regulatory strategy

Study protocol

KOL management

Budget management

Communication

Education

Bachelor's or Master's degree in scientific field/MD/ PhD

Job description

Intuitive Surgical, Inc. seeks a Senior Manager of Clinical Affairs to shape clinical strategies and oversee trials for emerging technologies. This role leads a team of study managers and CRAs, coordinating with regulatory, R&D, and PMO to meet regulatory submissions.

The position requires extensive experience in clinical studies, collaboration with KOLs and sites, and strong budgeting and data integrity skills, with travel up to 30–40%.