[Hiring] Executive Director, Head of Clinical Operations Excellence @BeiGene

Role Description

As a member of the GCO Leadership team, contribute significantly to the development of Clinical Development & GCO strategies and provide expertise and leadership in the areas of process, eTMF management, quality and compliance of all clinical operations conducted by the Global Clinical Operations Organization and its partners.

• Lead the development, implementation, and maintenance of a proactive GCP compliance management infrastructure/process, system within GCO.
• Ensure adherence to regulatory requirements (ICH, FDA, EMA, PMDA, etc.) and GCP/PV guidelines.
• In collaboration with QA, Corporate Compliance, GCO & Development peers/associates, identify root causes for major and critical observations.
• Develop GCO direct and indirect reports (e.g., Clinical Study Managers, CRAs…) to ensure greater value is added to the business across all areas and across regions.
• Inspire and lead efforts to deepen operations excellence within the Clinical Development and GCO organizations.

Qualifications

• BS, with advanced degrees preferred, in a scientific or healthcare discipline.
• At least 15 years in the biotech/pharma/CRO industry in a relevant field of Clinical Operations, Clinical Compliance, Clinical Monitoring, Clinical Trial Management, and/or Clinical Quality Assurance.
• Fluent in written and verbal English; knowledge of Mandarin is desirable.

Requirements

• Efficient in Microsoft Word, Excel, Project, PowerPoint, and Outlook.
• Excellent experience building GCP quality systems and processes, including development of SOPs, effective CAPA programs.
• Strong leadership for driving the progress on cross-functional alignment.
• Risk-based management skill and mindset.
• Skilled in Project Management, Root Cause Analysis, CAPA Management.
• Preferred experience with Six Sigma, LEAN, Agile methodologies.

Benefits

• Comprehensive benefits package including Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.
• Non-Commercial roles are eligible to participate in the annual bonus plan.
• Commercial roles are eligible to participate in an incentive compensation plan.
• All employees have the opportunity to own shares of BeOne Medicines Ltd. stock.
• Discretionary equity awards and participation in the Employee Stock Purchase Plan.

Salary Range

$271,800.00 - $351,800.00 annually. Actual compensation packages are determined by several factors unique to each candidate.