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Senior Director, Digital PV and Decision Support Capabilitie

Company: BeiGene, Ltd.
Location: Ridgefield Park
Posted on: February 13, 2021

Job Description:

Senior Director, Digital PV and Decision Support Capabilities Ridgefield Park Shanghai KCC San Mateo 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. Job Description: General Description:
This position is a global role responsible for actively influencing GPS strategy and providing broad and deep technical knowledge, practical experience and thought leadership to deliver revolutionary advances in the techniques applied within pharmacovigilance to enhance the speed accuracy and effectiveness of scientific and operational decision making. The role leads 3 functional areas, and serves to define the GPS vision and direction for the adoption of digital pharmacovigilance and is the chief consult to the GPS Leadership Team on all matters related to PV innovation. In addition, the role is responsible for the definition of governance rules used to develop and implement data quality standards for PV as well as the strategies and capabilities for accessibility and utilization of PV data. The role incumbent develops budget and investment strategies for new digital capabilities to support PV in collaboration with IT and finance; and establishes relationships and identifies mutual areas for collaboration between GPS and other functions. The role operates in conformance with the Global Patient Safety approved RASCI chart and is responsible for talent management and development of staff under their oversight.
Essential Functions of the job:
Process Monitoring, Insights & Optimization

  • Accountable for the establishment of procedures and practices used to assess and identify processes requiring optimization
  • Accountable for ensuring application of business process modeling notation mapping (or similar) to key pharmacovigilance business processes to enable Detailed end to end view of GPS process is clear visibility of handoffs and inter-functional deliverables as well as opportunities for continuous improvement
  • Establishes detailed end to end view of GPS process is to enable clear visibility of handoffs and Inter functional deliverables
  • Accountable for establishing GPS Key Performance Indicators (KPIs) used to measure process effectiveness
  • Accountable for ensuring trending of critical compliance and quality related issues
  • Accountable for the design and implementation of methodologies for root cause analysis of critical quality and compliance related issues such as corrective and preventive action (CAPA) investigations
  • Accountable for ensuring regulatory inspections and audits are support through the timely provision of data analysis related to quality and compliance of GPS business processes
  • Responsible for defining and executing on the strategy behind the assessment of key processes that need optimization
  • Provides governance over the definition and mapping of prioritized GPS processes to enable efficiency effectiveness continuous improvement and identification of opportunities for innovation
  • Directs efforts to establish a standard GPS toolkit for process analysis deliverables
  • Defines the vision and strategy for the development and implementation of the GPS Audit & Inspection-Risk (A-R) Traffic Control monitoring dashboard
  • Provides detailed insights into areas of risk and approaches for mitigation, in collaboration with subject matter experts during audits and inspections
  • Accountability for development and implementation of the GPS digital PV strategy in collaboration with key stakeholders
  • Accountable for development, implementation and adoption of capabilities used to support digital risk communication, improved patient risk management, and the understanding of patient insights in areas such as risk education & awareness. Safety Systems & Safety Information Management
    • Leads and guides strategy for safety information management and safety systems used in the fulfilment of pharmacovigilance
    • Provides leadership and guidance for all safety systems and information management related activities
    • Leads and defines business strategy and objectives for GPS systems by combining knowledge of technology trends and business need
    • Accountable for all business-related vendor relationships and collaborates with corporate IT to ensure maximize collaboration opportunities
    • Ensure business capabilities are in place to deliver continuous system availability
    • Leads, defines and executes on talent strategy and ensures availability of subject matter experts. Decision Support
      • Leads the strategy for the development and implementation of digital algorithms to support decision making within GPS
      • Defines innovation investment strategy to support development of new capabilities
      • Leads the evaluation and identification of scientific and operational decisions support requirements and develops proof of concepts for investigation within the PV innovation incubator
      • Applies knowledge of pharmacovigilance Sciences to define strategies for the application of artificial intelligence and machine learning to support decision making
      • Serves as thought leader and subject matter expert to internal stakeholder's strategic partners regulatory authorities and academic institutions in the application of artificial intelligence and machine learning within pharmacovigilance
      • Leads and defines the development and implementation of the GPS pharmacovigilance innovation strategy and roadmap including the application of artificial intelligence, machine learning and other relevant automation and assistive technologies.
      • Defines the GPS intelligent automation roadmap and strategy. Oversees execution of roadmap.
      • Responsible for leading the establishment of the GPS PV Innovation incubator, including innovation process management methods
      • Overseas the ongoing development and utilization of a tool kit for the conduct of innovation
      • Establishes strong business relationships, collaborations and partnerships and ensure alignment of business strategy with key internal and external stakeholders including academic institutions, regulatory authorities and healthcare institutions
      • Accountable for ensuring business input into strategic activities related to the utilization of technologies across GPS and the integration of GPS business needs into emerging cross-functional plans
      • Represents GPS on internal and external advisory bodies as well as key external industry PV technology innovation/collaboration projects. Inspection Readiness
        • Responsible for ensuring capabilities are in place to support GPS inspection readiness activities including but not limited to:
        • Production of compliance monitoring and process and activity reports
        • Data provisioning for the execution of root cause analysis activities
        • Provisioning of quality performance findings
        • Trending of critical compliance and quality related issues
        • Design and implementation of methodologies for root cause analysis of critical quality and compliance related issues
        • Ensure business continuity plans for technical capabilities are in place globally to minimize risk of disruption to global pharmacovigilance activities.
        • Represents Global Patient Safety as Digital PV & Decision Support Capability subject matter expert during audits and inspections.
        • Accountable for the coordination and conduct of landscape monitoring activities required to maintain up to date knowledge on emerging technologies
        • Accountable for implementing processes that support the conduct of technology pilots including but not limited to the recording of impact analyses on newly evaluated capabilities and appropriate knowledge dissemination to key stakeholders
        • Establishes relationships and communication forums with GPS stakeholders in collaboration with corporate IT to ensure timely knowledge sharing of emerging capabilities Functional Area Support
          • Accountable for the development of Digital PV & Decision Support Capability SOPs, templates, toolkits and working instructions.
          • Accountable for ensuring the technology and KPI related inputs required to support Global Patient Safety Pharmacovigilance System Master File (PSMF) is maintained in state of continuous inspection readiness
          • Ensures provision of support to ensure seamless and effective functioning of the roles and responsibilities of the EU QPPV
          • Ensure functional areas and senior management remain aware of digital PV and innovation strategies
          • Ensure innovations roadmaps are in place for each sub-functional areas within GPS
          • Supports communication and change management activities across Global Patient Safety to ensure successful implementation of strategic projects and initiatives as well as ensuring stakeholder awareness, adoption and advocacy of GPS value proposition
          • Supports benchmarking activities of capabilities, processes, and tools by providing subject matter expertise.
          • Contributes to strategic initiatives across GPS, as required Supervisory Responsibilities:
            Accountable for 11+ resources operating within Digital PV & Decision Support Capabilities functional area
            -- Education Required:
            • Bachelor's degree in life sciences or equivalent health experience
            • A relevant post-graduate qualification (e.g. MBA; or higher degree qualification in a relevant area of Information Management or Computer/Data Science)
              Competencies:
              Information Management - Expert understanding and application of due diligence principles in all areas of drug safety. Thought leader in modern information management principles and practices Quality & Compliance - Expert understanding of the need for data accuracy, completeness consistency and integrity. Understanding of the application of six-sigma and other techniques and tools for process improvement Data Analysis - Thought leader on the development of novel data analysis principles and techniques to draw out main messages from data and research 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 gets 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 - Expert ability to anticipate and contribute to the effective resolution of compliance issues. Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully. Critical Thinking - Identifies how different possible approaches are strong or weak and analyzes these judgments. Project Management - Communicates changes and progress; Completes projects on time and budget. Qualification Required: Experience
              • Minimum Twelve (12) years of experience in Biotech/pharmaceutical industry
              • Minimum Five (5) years of experience working with drug safety technologies
              • Minimum Five (5) years of experience with people leadership or team leadership experience.
              • Minimum Three (3) years of experience developing and implementing artificial intelligence, machine learning and knowledge management capabilities within regulated environments
              • Demonstrated experience leading Six Sigma and lean projects including but not limited to application of value stream mapping methodologies, BPMN Process Mapping, DMAIC, DMADV, Cause & Effect and SIPOC Analysis
              • Broad knowledge and experience in the application of ASQ/ANSI quality standards
              • Demonstrated experience leading teams working with business collaborations in the pharmacovigilance space
              • Broad experience leading teams implementing cross-functional partnerships and business processes
              • Demonstrated experience implementing business process optimizations and evaluation of effectiveness
              • Demonstrated experience managing a Key Performance Indicator (KPI) environment for operational business processes
              • Expert knowledge of existing technological and digital landscape related to biopharmaceutical research, clinical decision support, drug development, and/or patient engagement would be highly advantageous. Other Qualifications:
                • Six sigma certifications
                • Ability to understand the implications of lack of compliance for regulated processes
                • Ability to develop and influence relationships and partnerships (internal/external) across all levels of the organization, exhibiting strong leadership and influencing skills.
                • Excellent oral and written communications, including experience in public speaking and group facilitation.
                • Excellent interpersonal and customer service skills, and a high level of personal integrity.
                • Ability to deal with ambiguity and make decisions within a high-growth, rapidly evolving environment
                • Ability to anticipate strategic business needs to ensure patient safety operations remain proactive in the delivery of capabilities for the company
                • Strong analytic and strategic thinking skills with attention to detail Travel: International and domestic, up to 40% BeiGene is a global, commercial-stage, research-based biotechnology company focused on molecularly targeted and immuno-oncology cancer therapeutics. Currently employees are located in APAC, United States and Europe. BeiGene is advancing a pipeline consisting of novel oral small molecules and monoclonal antibodies for the treatment of cancer. BeiGene is working to create combination solutions aimed at having both a meaningful and lasting impact on cancer patients. For more information, see www.beigene.com.

Keywords: BeiGene, Ltd., Tenafly , Senior Director, Digital PV and Decision Support Capabilitie, Executive , Ridgefield Park, New Jersey

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