Position Summary:

• Oversee clinical operation activities in the Americas Countries

• Strategic planning and execution of clinical operations’ deliverables at the regional level

• Lead therapeutic area/s (TA) within Clinical Operations with responsibility for line management, strategic planning and alignment with broader organizational goals

• Provide a deep knowledge of therapeutic area and expert input and guidance on programs for appropriate, feasible and effective clinical trial designs and execution for specific disease areas / patient populations

• Establish BeiGene’s reputation and capability for successful delivery of clinical trials, in partnership with internal & external stakeholders

• Develop direct and indirect reports to ensure greater value is added to the business across all areas

• Inspire and lead efforts to deepen scientific knowledge within the Clinical Operations’ function to drive faster, high quality clinical trials

• Provide expert knowledge on the execution of clinical trials, expert understanding of ICH/GCP Guidelines and other applicable regulatory requirements

Essential Functions of the Job:

• Ensures timely planning and delivery of clinical trials with high quality in the responsible countries or region

• Contributes to and has accountability for overall Clinical Operations strategy and performance against key metrics

• Maintains a positive and results orientated work environment

• Drives team members to improve their efficiency and effectiveness at prioritizing work and improving performance

• Develops training plans and programs across Clinical Operations to enhance project management skills

• Ensures that multiple, novel ideas on how to deliver on clinical trials are generated and considered

• Actively oversees the knowledge management process by ensuring information is captured, retained, and leveraged for future work

• Ensures operational processes, systems and standards are adopted and implemented consistently across trials

• Contributes to Clinical Operations and clinical trial sourcing strategy development and takes a lead role in vendor governance

• Champions a global mindset and approach across Clinical Operations to foster increased collaboration and consistency across BeiGene

• Ensures alignment with broader BeiGene strategic initiatives and business needs and provides recommendations or ideas on how Clinical Operations’ programs can generate greater value for BeiGene overall

• Ensures Clinical Operations thinking and activities are aligned with overall business direction and priorities

• Identifies opportunities and initiatives within the broader organization that can be adopted/adapted by Clinical Operations as best practice; equally recommends best practices within Clinical Operations that if more broadly applied would benefit BeiGene as a whole

• Maintains a working knowledge of, and assures compliance with, applicable ICH Guidelines, Good Clinical Practices, Regulatory Agency requirements, and SOPs

• Implements and revises SOPs and monitors departmental compliance

• Participates in formal staff performance review processes

• Communicates with internal and external staff effectively with a professional and collaborative approach.

• Escalates issues to BeiGene Senior Management team timely

• Demonstrates strong initiative in activities through the clinical trials and other company initiatives

• Proactively identifies potential issues and seeks improvement

• Takes initiative for issue resolution within and outside the Clinical Operations department

• Coordinates the risk management process encompassing proactive risk identification, evaluation (probability and impact) and mitigation plans

Requirements:

• Bachelor or higher degrees (life science preferred, including medicine, nursing, biology and laboratory technology)

• Fluent in written and verbal English

• 14+ years in the biotech/pharmaceutical/CRO industry

• Minimum of ten years of project management and/or clinical operation experience

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.