Executive Director, Global Clinical Operations Americas

BeiGene 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.

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

BeiGene Global Competencies

When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

• Fosters Teamwork
• Provides and Solicits Honest a