Vice President, Global Clinical Operations, Americas

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• As a member of the GCO Leadership team, participates in the development of Clinical Development & GCO strategies and provides expertise and leadership in the area of Clinical Operations activities in the Americas (North, Central, and South) and at the study/therapeutic area levels
• Strategically plan and execute clinical operations’ deliverables at the region and/or Country level. Proactively identifies potential strategic issues/opportunities
• 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 impacts the business on a global scale
• 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 BeOne’s reputation and capability for successful delivery of clinical trials, in partnership with CROs when necessary
• Develop direct and indirect reports (e.g., Clinical Operations Managers, Compliance) 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

• Member of the Global Clinical Operations Leadership team
• 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 BeOne
• Ensures alignment with broader BeOne strategic initiatives and business needs and provides recommendations or ideas on how Clinical Operations’ programs can generate greater value for BeOne 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 BeOne 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 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 (probability and impact) and mitigation plans
  
  

Education And Experience Required

• Bachelor or higher degrees (life science preferred, including medicine, nursing, biology and laboratory technology)
• 14 years in clinical or drug development in the biotech/pharmaceutical/CRO industry or the relevant clinical research field
• Minimum of ten years of project management and/or clinical operations experience
  
  

Supervisory Responsibilities

• 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
  
  

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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