Global Director, Clinical Operations & Compliance

Regulatory Jobs; United States; Remote; USD 272,000 - 352,000; Full time

Job summary

BeOne Medicines Ltd. in the United States seeks a senior leader to advance Clinical Development and GCO strategies, ensuring GCP compliance, eTMF integrity, and streamlined operations across global trials.

You will build and mentor a capable team, drive KPI reporting, lead audits, CAPA management, and partner with QA, Corporate Compliance, and Development to deliver high-quality studies. This role requires deep regulatory knowledge, cross-functional influence and a track record of improving

Qualifications

• 15+ years in biotech/pharma/CRO in Clinical Operations, Clinical Compliance, Clinical Monitoring, Trial Management, or QA.
• Fluent in written and verbal English; Mandarin knowledge desirable.
• Strong leadership for cross-functional alignment and risk-based management.

Responsibilities

• Lead end-to-end clinical trial excellence oversight of SOPs and related processes.
• Develop, implement and revise SOPs; monitor compliance.
• Oversee eTMF platform and CAPA programs; ensure inspection readiness.

Skills

GCO leadership

Quality management

Regulatory compliance

Project management

SOP development

Training programs

Education

BS in scientific/healthcare

Tools

MS Word

Excel

Project

PowerPoint

Outlook

Job description

BeOne Medicines Ltd. in the United States seeks a senior leader to advance Clinical Development and GCO strategies, ensuring GCP compliance, eTMF integrity, and streamlined operations across global trials.

You will build and mentor a capable team, drive KPI reporting, lead audits, CAPA management, and partner with QA, Corporate Compliance, and Development to deliver high-quality studies. This role requires deep regulatory knowledge, cross-functional influence and a track record of improving