Global Clinical Operations Director

BeOne Medicines Ltd.; Emeryville (CA); On-site; USD 180,000 - 260,000; Full time

Job summary

BeOne Medicines Ltd. is seeking a senior Clinical Operations leader to shape GCO strategies and drive quality, compliance, and operational excellence across global trials.

You will lead eTMF management, oversee CAPAs, and build a high-performing team, ensuring regulatory alignment with ICH, FDA, EMA and PV guidelines while advancing process improvements worldwide. Your experience in clinical operations, CAPA management, and cross-functional leadership will help accelerate high-quality trials and

Qualifications

• BS, with advanced degrees preferred, in a scientific or healthcare discipline.
• At least 15 years in biotech/pharma/CRO in Clinical Operations, Clinical Compliance, Clinical Monitoring, or Clinical Quality Assurance.
• Experience building GCP quality systems and SOPs, CAPA programs, and cross-functional alignment.

Responsibilities

• Lead end-to-end clinical trial excellence oversight of SOPs and related procedures.
• Develop, implement and revise SOPs; monitor departmental compliance across trials.
• Ensure operational processes, systems and standards are adopted consistently across trials.
• Develop and report clinical KPIs/KQIs and provide updates to senior leadership.
• Oversee eTMF platform management, training, and inspection readiness.

Skills

Leadership

Quality management

GCP compliance

Process improvement

Training development

KPIs/KQIs

eTMF management

Regulatory knowledge

Cross-functional leadership

Project management

Risk management

Education

Bachelor's degree in a scientific discipline

Advanced degree preferred

Tools

Microsoft Word

Excel

PowerPoint

Outlook

Project

Job description

BeOne Medicines Ltd. is seeking a senior Clinical Operations leader to shape GCO strategies and drive quality, compliance, and operational excellence across global trials.

You will lead eTMF management, oversee CAPAs, and build a high-performing team, ensuring regulatory alignment with ICH, FDA, EMA and PV guidelines while advancing process improvements worldwide. Your experience in clinical operations, CAPA management, and cross-functional leadership will help accelerate high-quality trials and