Executive Director, Head of Clinical Operations Excellence

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

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...