Global Clinical Operations Leader

Bill & Melinda Gates Foundation; Cambridge (MA); On-site; USD 211,000 - 363,000; Full time

Benefits offered by this job

Flexible work arrangements (local 50%

Relocation package

Remote arrangements may be available

Job summary

Gates MRI in Cambridge, MA, seeks a Clinical Operations Leader to drive the strategic execution of complex clinical trials across programs.

You will lead a hands-on operations team, oversee outsourced operations, ensure GCP/ICH compliance, and manage budgets and timelines. The role emphasizes collaboration with partners worldwide, risk management, and building scalable clinical infrastructure.

Qualifications

• 15+ years of clinical operations experience in biotech/pharma or CRO.
• 5+ years of people management experience.
• BA/BS in science or healthcare (nursing acceptable).
• Proven CRO oversight, vendor selection, contract negotiation, and budgeting.
• Experience with outsourced/FSP delivery models and sponsor oversight.
• Deep knowledge of GCP, ICH guidelines and US FDA regulations.
• Ph III experience; global trials with LMIC exposure a plus.
• Strong leadership, communication and diplomacy skills.
• Willingness to travel ~20% locally and internationally.

Responsibilities

• Provide strategic leadership to ensure trials run on time and budget.
• Serve as the functional lead for Development Operations and sponsor oversight.
• Ensure readiness for inspections with proper oversight documentation.
• Develop risk management plans and escalate issues when needed.
• Collaborate with partners and FSPs to drive KPIs and governance.
• Help build clinical operations infrastructure and SOPs.

Skills

Leadership

People management

Communication skills

GCP knowledge

Vendor oversight

Budget management

Global health experience

Education

Bachelor's degree in science/healthcare

Job description

Gates MRI in Cambridge, MA, seeks a Clinical Operations Leader to drive the strategic execution of complex clinical trials across programs.

You will lead a hands-on operations team, oversee outsourced operations, ensure GCP/ICH compliance, and manage budgets and timelines. The role emphasizes collaboration with partners worldwide, risk management, and building scalable clinical infrastructure.