Executive Director, Head of Clinical Operations Excellence

General 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 managemnt, 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, including clinical trial oversight processes, monitoring and quality control of key processes (eTMF), standard operating procedures and/or 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 the use of innovative and agile methodology to improve processes.

• In collaboration with QA, Corporate Compliance, GCO & 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 across 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.

Essential Functions of the Job:

• Member of the Global Clinical Operations Leadership team

• Participate in the development of Clinical Development & GCO strategies and provides expertise and leadership in the area of 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 or ideas 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.

• Quality Indicators and assure that gaps are addressed appropriately in order to mitigate risk.

• Work in collaboration with Clinical Development functions as necessary.

• Explore and implement innovative ways, including standardization, to increase Clinical Operations excellence around the world; this 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.

• Actively ensure Training compliance is best and meets Corporate and GCO goals.

Performance Metrics:

• Develop, Establish and Report clinical performance indicators KPIs/KQIs, which are related Quality and Complaince.

• Provide updates of performance and quality to the Clinical Development senior leadership and/or EC 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 of the GCO organization. Support proactive monitoring and assessment of compliance risks. Prepare the organization for inspections.

• Identify emerging compliance concerns and review SOP deviations that impact GCO, conduct root cause analyses, and recommend solutions.

• Ensure assessment and resolution of all CAPAs are completed on time. Verify that appropriate CAPAs are implemented on all major and critical audit/inspections findings.

• Oversee processes and plans for development of relevant remedial and improvement actions for Preventative Action Plans from Audits/Inspections/Incidence and responsible for follow-up on completion and implementation of relevant tasks within GCO.

eTMF:

• Maintain and optimize the platform serving for eTMF .Leverage AI for further improving the efficiecy.

• Set up SOP and/or WI, lead the change maangement and oversight team’s actual performance on eTMF.

• Join in inspection preparation and conduction for securing the success on inspection.

Other functions but not limited to:

• 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 as it relates 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 as well as in the global GCO function.

• Mentor and coach the GCO teams as necessary.

Education Required:

• 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.

Computer Skills:

• Efficient in Microsoft Word, Excel, Project, PowerPoint, and Outlook.

Other Qualifications:

• Fluent in written and verbal English. Desirable: knowledge of Mandarin.

• Excellent experience building GCP quality systems and process, 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.

Travel: Up to 25%

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.