Executive Director, Global Clinical Operations Americas
BeiGene
**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.
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