Director, Clinical Ops Excellence & Compliance

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

Benefits offered by this job

Medical benefits

401(k)

Paid time off

Job summary

BeOne Medicines Ltd. is seeking a senior Global Clinical Operations leader in the United States. The role focuses on developing and maintaining GCP-compliant processes, eTMF management, and performance improvement across global trials.

You will lead a multi-national team, drive KPI reporting, SOP development, and cross-functional collaboration with QA, Development, and CROs. Travel up to 25% is expected.

Qualifications

• BS, with advanced degrees preferred.
• At least 15 years in biotech/pharma/CRO in Clinical Operations, Clinical Compliance, or Clinical Quality Assurance.
• Fluent in written and spoken English; Mandarin knowledge desirable.

Responsibilities

• Lead end-to-end GCO quality, compliance, and operations excellence across clinical trials.
• Develop and maintain SOPs, eTMF, CAPA, and Training programs.
• Build and mentor a high-performing global team; report KPIs/KQIs to senior leadership.
• Collaborate with QA, Development, CROs, and other functions to drive value and improvements.

Skills

Leadership

Project management

Root cause analysis

CAPA management

Six Sigma / LEAN

GCP compliance

Cross-functional collaboration

Education

BS with advanced degree preferred

15+ years biotech/pharma/CRO

Tools

Microsoft Word

Excel

Project

PowerPoint

Outlook

Job description

BeOne Medicines Ltd. is seeking a senior Global Clinical Operations leader in the United States. The role focuses on developing and maintaining GCP-compliant processes, eTMF management, and performance improvement across global trials.

You will lead a multi-national team, drive KPI reporting, SOP development, and cross-functional collaboration with QA, Development, and CROs. Travel up to 25% is expected.