BeOne Medicines

Key Responsibilities

• • Participates in the development of Clinical Development & GCO strategies and provides expertise and leadership in Clinical Operations activities in the Americas and at the study/therapeutic area levels
• • Strategically plan and execute clinical operations’ deliverables at the region and/or Country level
• • Develops organizational policies/standards and implements them within a function or across functions in GCO or R&D
• • Leads large cross-functional projects/initiatives that impact the business on a global scale
• • Lead therapeutic area/s within Clinical Operations with responsibility for line management, strategic planning and alignment with broader organizational goals
• • Provide expert input and guidance on programs for clinical trial designs and execution for specific disease areas / patient populations
• • Establish BeOne’s reputation and capability for successful delivery of clinical trials, in partnership with CROs when necessary
• • 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 Clinical Operations to drive faster, high quality clinical trials
• • Provide expert knowledge on the execution of clinical trials and understanding of ICH/GCP Guidelines and other regulatory requirements
• • 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
• • Ensures alignment with broader BeOne strategic initiatives and business needs and provides recommendations on how Clinical Operations’ programs can generate greater value
• • 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
• • 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 BeOne 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 and mitigation plans
• • Line Management of Direct and/or indirect line reports
• • Manage internal staff and/or coordinate internal and external contractors/resources to ensure timeliness and quality delivery of clinical trials in the country and region
• • Mentor and coach the GCO teams as necessary