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Head of Clinical Data Engineering

Company: Takeda Pharmaceutical
Location: North Easton
Posted on: August 7, 2022

Job Description:

By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge.

Job Description

The Data Sciences Institute (DSI) within R&D plays an integral role in bringing our clinical data together so we can draw new insights and have a better sense of the impact of our potential medicines beyond the standard clinical setting Takeda is advancing an exciting pipeline and wants to ensure that we have the infrastructure and talent in place to support it. Our overall goal is to ensure that we get our therapeutics to patients quickly by having the right operational model and integrated clinical data pipeline to support delivery.

The Clinical Data Engineering team serves as the subject matter experts for EDC platforms (e.g. Medidata Rave , Oracle InForm ) and clinical and research data processing, including stewardship of the external-data ( edata ) standards, e CRF standards - inclusive of data acquisition and review, and data consumption models to enable planning, coordination, execution, and timely delivery of complete, high quality and reliable clinical trial data for internal decision-making, regulatory approval, and market acceptance.

Data Engineering's role is central to Takeda clinical trials from study start up through data base lock, with the primary goal of ensuring delivery of high quality clinical trial data, efficiently, cost-effectively, and in compliance with Good Clinical Practice (GCP) . The Data Engineering team will s erve as a resource to support questions raised by regulatory agencies.

The Head of Clinical Data Engineering is expected to:

  • Lead a group of EDC database builders, d ata e ngineers and clinical data management programmers who develop data pipelines, programs and tools that serve different business needs, including but not limited to: acquire structured and unstructured data in support of Takeda clinical trials, generate reports/outputs to aid in data review and to perform data quality checks for the purpose of data cleaning, collaborate with different internal organizations and teams to integrate data pipeline from various systems/platforms, develop standardization, and innovate and use of latest data tools and technologies
  • Foster and ensure close collaboration with Clinical, Clinical Data Managers, Clinical Technology Specialists, Statistical Programmers, Statisticians and other stakeholders in the clinical data lifecycle
  • In collaboration with the system and architecture team, d rive decisions on end-to-end systems selection & implementation, process improvement and data standards opportunities to ensure and optimize the use of automation and AI/ML .
  • R epresent Data Engineering as needed during audits and regulatory inspections
  • Accountable for the review, development, maintenance and optimization of processes and standard operations to ensure that data engineering programming and validation activities are in compliance with regulatory and company requirements
  • Show influential strategic, execution and delivery leadership both within Takeda and outside of Takeda with vendors and partners .

    Strategic Planning and Execution
    • Partners with relevant stakeholders within the global data program to define priority solutions and processes in support of the data and digital strategy
    • Create , operationaliz e & roll-out the roadmap for strategic direction of the Data Engineering team
    • Reports on progress of projects, issues/plans, and critical path schedules to executive leadership
    • Drive global functional strategy related to innovation in resourcing, technologies and automation, processes and standards to maximize efficiency and quality
    • Visibly engages across the organization to ensure transformational impact .

      Fiscal Responsibility
      • Responsible Data Engineering operating budgets; monitor and control expenditures; manages variance between budgeted and actual expenditures of time, dollars, and personnel while meeting overall Takeda financial objectives.

        Resource and Issue Management
        • Manages internal and external resources (people, information, technologies, time and capital); allocates project resources appropriately to align with business imperatives.
        • Proactively identifies project issues before they arise and develops contingency plans; communicates project-related issues to senior executive management and manages issues to resolution.

          Change Management
          • As a leader in a large, transformational program, supports strategies for effecting change, controlling change and helping people to adapt to change.

            Matrix Team Management

            Provides matrix management, strategic and tactical leadership across data program.

            Technical/Functional (Line) Expertise
            • Seasoned R&D leader with deep knowledge in clinical trial data including data sources , data models and data standards; clinical data systems and platforms, software and program development and implementation; knowledge and expertise in developing AI-based algorithms.
            • Ability to create and deliver technical and methodology projects and guides them to implementation across R&D .
            • Expert level ability to understand evidence gaps across all types of clinical and operational questions and the ability to identify and implement Data Science-based solutions. Leadership
              • Demonstrated ability to work across functions, regions and cultures
              • Functional level leadership with the ability to inspire, motivate and drive results
              • Excellent communicator, able to persuasively convey both ideas and data, verbally and in writing
              • Proven skills as an effective team player who can engender credibility and confidence within and outside the company
              • Ability to distil complex issues and ideas down to simple comprehensible terms
              • Demonstrates leadership presence and confidence
              • Embraces and demonstrates a diversity and inclusion mindset and role models these behaviors for the organization
              • Builds teams across functions and geographies with individuals who have the right skills and experience to deliver on key organizational initiatives.
              • Invests time in helping others to enhance their skills and perform at a higher level Decision-making and Autonomy
                • Decision making responsibilities:
                  • Provide input to highly complex decisions that impact the functional area
                  • Accountable for decision making for designated function
                  • Ability to seek diverse input from multiple constituents and stakeholders to drive innovative solutions
                  • Ability to incorporate feedback and ensure decisions are implemented swiftly to yield flawless execution
                    • Accountable for providing input to and implementing vision and strategy for designated scope Interaction
                      • Effectively navigates the changing external and internal environment and leads others through change by creating and inspiring and engaging workplace
                      • Cultivates a broad network of relationships throughout Takeda, with affiliates and external partners, in the industry and area of expertise.
                      • Effectively represents function in negotiations with the ability to resolve conflict in a constructive manner
                      • Ability to build strong relationships and collaborate effectively with other interfacing Takeda functions Innovation
                        • Forward thinking with the ability to recommend, influence and implement organizational change and continuous innovation
                        • Comfortable challenging the status quo and bringing forward innovative solutions
                        • Ability to take risks implementing innovative solutions, accelerating time to market
                        • Identifies opportunities and anticipates changes in the business landscape through an understanding and ongoing assessment of the environment affecting the business.
                        • Role models respect and inclusion, creating a culture that fosters innovation Complexity
                          • Ability to work in a global ecosystem (internal and external) with a high degree of complexity
                          • Ability to see and understand broader, enterprise level perspective
                            • PhD with 12+ years experience or MS with 15 years experience in the pharmaceutical industry or healthcare sector , with joint experience / degree in Computer Science, Medical Informatics or Bioinformatics.
                            • Previous experience leading a medium to large organization and influencing senior-level management and key stakeholders is a plus
                            • Proven track record of leading and driving business process transformation and organizational culture change as well as delivering on programs with complex business deliverables
                            • Track record of successful leadership, management, and development of large, multi-disciplinary globally dispersed teams. Strong judge of talent with the ability to make tough talent decisions.
                            • Health care business acumen with a comprehensive understanding of the pharmaceutical industry
                            • Experience building/maintaining ETL pipelines..... click apply for full job details

Keywords: Takeda Pharmaceutical, Boston , Head of Clinical Data Engineering, Healthcare , North Easton, Massachusetts

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