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Senior/Executive Director, Clinical Operations Head of Americas

Company: BeiGene
Location: San Mateo
Posted on: November 22, 2021

Job Description:

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.

General Description:

  • 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 (Executive Director only)
  • Develops organizational policies/standards and implements them, within a function or across functions in GCO or R&D (Executive Director only)
  • Leads large cross-functional projects/initiatives that impacts the business on a global scale (Executive Director only)
  • 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 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 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
      Education Required: Bachelor or higher degrees (life science preferred, including medicine, nursing, biology and laboratory technology);

      More than 12 years (Senior Director) or more than 15 years (Executive Director) 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 operation 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

        Ethics - Treats people with respect; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.

        Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently. Completes administrative tasks correctly and on time. Follows instructions and responds to management direction.

        Communication - Listens and asks for clarification; Responds well to questions; Speaks clearly and persuasively in positive or negative situations. Writes clearly and informatively. Able to read and interpret written information.

        Teamwork - Balances team and individual responsibilities; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Supports everyone's efforts to succeed. Contributes to building a positive team spirit; Shares expertise with others.

        Adaptability - Able to adapt to changes in the work environment. Manages competing demands. Changes approach or method to best fit the situation. Able to deal with frequent change, delays, or unexpected events.

        Technical Skills - Assesses own strengths and development areas; Pursues training and opportunities for growth; Strives to continuously build knowledge and skills; Shares expertise with others.

        Dependability - Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan.

        Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.

        Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data.

        Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully.

        Project Management - Proactively communicates changes and progress; Completes projects on time and budget.

        Computer Skills : Efficient in Microsoft Word, Excel, Project, Powerpoint and Outlook

        Other Qualifications :

        --- Fluent in written and verbal English. Desirable: knowledge of Mandarin

        --- Excellent experience in clinical development activities, systems, and technologies

        Travel: As Needed, based on business need

        We are proud to be an equal opportunity employer and we value diversity. BeiGene does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.

Keywords: BeiGene, San Mateo , Senior/Executive Director, Clinical Operations Head of Americas, Healthcare , San Mateo, California

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