Executive Director, Head of Clinical Operations Excellence

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. We look for scientific and business professionals who are highly motivated, collaborative, and share our passionate interest in fighting cancer.

About the role

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 within GCO, including clinical trial oversight processes, monitoring, and quality control of key processes (eTMF), standard operating procedures (SOPs), work instructions, training, and change management.
• Build and lead a team with substantial capabilities to impact the continuous improvement of infrastructure and systems.
• Ensure adherence to regulatory requirements (ICH, FDA, EMA, PMDA, etc.) and GCP/PV guidelines through establishment and reporting of clinical performance indicators (KPIs/KQIs) and through innovative, agile methodology to improve processes.
• In collaboration with QA, Corporate Compliance, GCO, and Development peers/associates, identify root causes for major and critical observations, devise relevant remedial and improvement actions for Corrective Action Plans, and follow up on completion, implementation, and effectiveness of relevant tasks within GCO/Development.
• 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 regions.
• Inspire and lead efforts to deepen operations excellence within the Clinical Development and GCO organizations to drive faster, high-quality clinical trials around the world.

Responsibilities

• Leadership: Participate in the development of Clinical Development & GCO strategies and provide expertise in quality, compliance, and operations excellence in all aspects of clinical trials operations conducted by GCO and its partners (Clinical/Medical, Data Management, Clinical Supplies, PV, Statistics, QA, CROs, FSP, etc.). Provide recommendations on how Global Clinical Operations’ programs can generate greater value for BeOne.
• Procedures: Lead end-to-end clinical trial excellence oversight of Standard Operating Procedures. Develop, implement, and revise SOPs. Monitor departmental compliance to established procedures and policies. Ensure operational processes, systems, and standards are adopted and implemented consistently across trials.
• Process Improvement: Proactively identify internal process improvements within GCO through monitoring of adequate Key Performance and Quality Indicators and ensure gaps are addressed to mitigate risk. Explore and implement innovative ways, including standardization, to increase Clinical Operations excellence globally in collaboration with BeOne Clinical Development and Applied Innovation functions.
• Training: Develop training plans and programs across Global Clinical Operations and other clinical development functions as necessary. Actively monitor knowledge management by ensuring information is applied, retained, and leveraged for future work. Ensure training compliance meets Corporate and GCO goals.
• Performance Metrics: Develop, establish, and report clinical performance indicators (KPIs/KQIs) related to quality and compliance. Provide updates on performance and quality to Clinical Development senior leadership and/or Executive Committee as necessary.
• Compliance and eTMF: Develop, implement, and maintain the GCO Compliance Management Plan, including eTMF. Oversee the relationship with CQA to support and ensure compliance with GCP, SOP, and training requirements. Support proactive monitoring and assessment of compliance risks. Prepare the organization for inspections. Identify emerging compliance concerns, review SOP deviations impacting GCO, conduct root cause analyses, and recommend solutions. Ensure assessment and resolution of all CAPAs are completed on time. Verify appropriate CAPAs are implemented for all major and critical audit/inspection findings. Oversee processes for development of remedial and improvement actions for Preventative Action Plans from audits/inspections/incidents and follow up on completion and implementation.
• eTMF Management: Maintain and optimize the platform serving for eTMF. Leverage AI for further improving efficiency. Set up SOPs and/or work instructions, lead change management, and oversee the team’s actual performance on eTMF. Participate in inspection preparation and conduction to secure success.
• Other Functions: Contribute to GCO and Clinical Trial Sourcing strategy development and take a lead role in vendor due diligence. Escalate issues to BeOne Senior Management team timely. Lead multi-functional, multi-national teams related to quality conduct of clinical trials.
• Supervisory Responsibilities: Direct and indirect line management. Manage internal staff and/or coordinate internal and external contractors/resources to maintain GCP compliance in the field organization and global GCO function. Mentor and coach the GCO teams as necessary.

Requirements

• 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.

Skills

• Efficient in Microsoft Word, Excel, Project, PowerPoint, and Outlook.
• Fluent in written and verbal English. Desirable: knowledge of Mandarin.
• Excellent experience building GCP quality systems and processes, including development of SOPs and effective CAPA programs.
• Strong leadership for driving progress on cross-functional alignment.
• Risk-based management skills 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 programs.
• Opportunity to participate in the annual bonus plan (non-commercial roles) or incentive compensation plan (commercial roles).
• Eligibility for discretionary equity awards and voluntary participation in the Employee Stock Purchase Plan.

Pay

Salary range: $271,800.00 - $351,800.00 annually. Actual compensation is determined by several factors unique to each candidate, including job-related skills, depth of experience, certifications, relevant education or training, and specific work location.

Schedule

Travel: Up to 25% globally.