Senior Manager, Global Clinical Trials & Strategy

Intuitive; Sunnyvale (CA); On-site; USD 158,000 - 186,000; Full time

Job summary

Intuitive, a global leader in robotic-assisted surgery, seeks a Senior Manager of Clinical Affairs to drive clinical strategies and oversee study execution for emerging technologies. This role spans US and global trials, including first-human-use and pivotal studies for regulatory submissions.

You will lead a team of clinical operations personnel, work with cross-functional partners, and ensure compliance with GCP and regulatory guidelines while shaping clinical study strategy and dissemination

Qualifications

• Minimum education as listed: bachelor’s/master’s/MD/PhD with extensive experience.
• 5+ years independently managing clinical studies through multiple phases.
• Strong cross-functional collaboration and leadership abilities.
• Experience with regulatory submissions and clinical study documentation.
• Travel up to 30-40% as required.

Responsibilities

• Lead clinical study strategy development to meet business goals.
• Oversee protocols, CRFs, data management, and statistical plans.
• Manage budget and resources for timely, compliant studies.
• Collaborate with Regulatory, R&D, and commercial teams to optimize studies.
• Develop and mentor a team of CSMs and CRAs.

Skills

Clinical operations management

Cross-functional leadership

Regulatory strategy

Budget management

Education

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

12+ years of professional experience

Tools

GCP

21 CFR part 812

ISO14155

Job description

Intuitive, a global leader in robotic-assisted surgery, seeks a Senior Manager of Clinical Affairs to drive clinical strategies and oversee study execution for emerging technologies. This role spans US and global trials, including first-human-use and pivotal studies for regulatory submissions.

You will lead a team of clinical operations personnel, work with cross-functional partners, and ensure compliance with GCP and regulatory guidelines while shaping clinical study strategy and dissemination