Clinical Affairs PMO Leader – Medical Device Programs

Intuitive; California (MO); On-site; USD 180,000 - 260,000; Full time

Job summary

Intuitive is a global leader in robotic-assisted surgery and minimally invasive care. The Managing Principal, Project Management – Clinical Affairs partners with R&D, Regulatory Affairs, Clinical Development Engineering, Quality, and Business Unit PMOs to drive disciplined planning and execution of clinical studies and regulatory submissions.

The ideal candidate brings 10+ years in the medical device space, strong leadership, and a proven ability to lead cross-functional teams, manage risk and

Qualifications

• Minimum 10 years of experience in the medical device industry.
• Minimum 4 years of leadership and team management experience.
• Minimum 3 years of clinical project management experience.
• Deep familiarity with all stages of clinical studies and the product development lifecycle.
• Strong understanding of global regulatory standards (FDA, EU MDR, ISO 14155, ICH GCP).
• Proficiency with Project Management industry standards; PMP preferred.
• Proficiency with PM tools such as Smartsheet and MS Project.
• Excellent communication and executive presence; capable of influencing stakeholders.
• Strong negotiation, influencing, and change-management skills.
• Proven ability to lead cross-functional teams across R&D, Regulatory, and QA.

Responsibilities

• Lead strategic PMO and cross-functional leadership for clinical affairs programs.
• Oversee planning and initiation of Clinical Affairs activities across studies and regulatory deliverables.
• Develop integrated project plans with scope, timelines, dependencies, resourcing, and deliverables.
• Coordinate within Clinical Affairs subfunctions to ensure timely execution of study and submission deliverables.
• Ensure alignment with product development lifecycle and cross-functional dependencies.
• Provide portfolio updates to executive leadership via dashboards and KPIs.
• Standardize PMO processes and KPIs to enable program success across clinical portfolios.
• Develop and manage project charters, plans, and RFPs; monitor cost and spend.

Skills

10+ years medical device experience

4+ years leadership

3+ years clinical project management

clinical lifecycle knowledge

regulatory standards knowledge

PM standards & PMP

PM tools proficiency (Smartsheet)

PM tools proficiency (MS Project)

cross-functional leadership

negotiation & change management

communication & executive presence

people management

Education

Bachelor's degree in Life Sciences/Engineering

Master's degree (MS/MBA)

PMP certification

Tools

Smartsheet

MS Project

Job description

Intuitive is a global leader in robotic-assisted surgery and minimally invasive care. The Managing Principal, Project Management – Clinical Affairs partners with R&D, Regulatory Affairs, Clinical Development Engineering, Quality, and Business Unit PMOs to drive disciplined planning and execution of clinical studies and regulatory submissions.

The ideal candidate brings 10+ years in the medical device space, strong leadership, and a proven ability to lead cross-functional teams, manage risk and