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Trial Operations Data Lead - Alta Petens

Company: Takeda Pharmaceutical
Location: Weymouth
Posted on: November 25, 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

Takeda is a global, values-based, R&D-driven, top 10 biopharmaceutical leader committed to discover and deliver life-transforming treatments, guided by our commitment to patients, our people and the planet.

Our Data Sciences Institute (DSI) is made up of experts who harness the insight of data and digital to speed the development of highly innovative treatments to patients. These scientists (from statistics, programming, outcomes research and epidemiology, quantitative clinical pharmacology, digital strategy, library sciences and data architecture/governance) bring their expertise to our global program teams and re-imagine our disciplines. They work with novel data streams, including real-world data and digital tools, and apply advanced analytics including artificial intelligence and automation.

Takeda DSI is looking to add individuals to our team that are team oriented, collaborative, have strong understanding of data science disciplines, and are exceptional leaders and innovators. DSI aspires to bring safe and effective medications to patients with our quantitative skills, our use of technologies, models and methods for data processing, and our science driven data analytics.

The Trial Operations Data Lead is responsible for leading the systems, governance, and insights transformation for trial operational data. This transformation will include an integrated data flow with end-to end control of data, internalization and replacement of numerous systems and processes, broad enablement of automation and near-time data access, routine insights across the pipeline to enable reliable predictable delivery, and enablement of disruptive technologies for next-gen trial designs and insights. The data program will encompass all systems, platforms and tools involved in the collection, processing, review, analysis, and downstream consumption of trial operations data and will be inclusive of all Takeda therapeutic areas and relevant business units.

Delivery & Business Accountabilities

The Trial Operations Data Lead is expected to:

  • Lead the operational data transformation to support Takeda R&D's vision to create a development engine and ecosystem that provides optimal clinical data control and quality in a predictable, automated & cost-effective way
  • Lead multi-faceted business process mapping to inform future-state operational data flow and system and architecture design; Work with other leaders to ensure impact is well-understood and accounted for within broader future fit development workstreams
  • Lead the selection and implementation of operational data vendors, systems, platforms, and tools to support a transformed global data program, including advanced systems and tools to support risk-based quality and study management
  • Establish and embed appropriate quality oversight and governance throughout data program following R&D policies
  • Oversee or manage key resources working on the operational data transformation team and operational data ecosystem
  • Engage and direct product owners and other supporting roles for all systems, data models and tools within operational data ecosystem
  • In collaboration with other leaders, create and manage transition plans from former state to transformed state and lead or contribute to future-state processes
  • Show influential strategic, execution and delivery leadership both within Takeda and outside of Takeda with vendors and partners
  • Provide strategic vision for long-term delivery innovation CORE ELEMENTS RELATED TO THIS ROLE

    Strategic Planning and Execution
    • Lead in setting operational data goals, priorities, plans and schedules. Align and coordinate with corresponding workstreams and initiatives.
    • Visibly engages across the organization to ensure transformational impact Fiscal Responsibility
      • Manage expenditures; manage variance between budgeted and actual expenditures of time, dollars, and personnel while meeting overall Takeda financial goals. Resource and Issue Management
        • Manage our resources (people, information, technologies, time, and
        • Identify project issues before they arise and develops contingency plans; communicate project-related issues to senior executive management and manages issues to resolution. Change Management
          • Support strategies for effecting change, controlling change and helping people to adapt to change. Matrix Team Management
            • Provide matrix management, strategic and tactical leadership across data program.
              EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
              • Minimum of 10 -12 years of experience with advanced degree or 15+ years for bachelor's degree in pharmaceutical, CRO, healthcare or related industry
              • Knowledge and/or experience within clinical trial operations and clinical trial lifecycle
              • Knowledge of R&D technologies and data sources
              • Prior experience in process development management, inspection readiness, TMF and clinical systems
              • Solid understanding of system development lifecycle requirements and of US CFR, GCP, ICH and the clinical development process
              • Strong leadership skills with wide range of global R&D stakeholders
              • Tolerance of ambiguity and willingness to work through complex issues
              • Ability to work with global external partners to achieve desired goals
              • Ability to develop solutions to complex issues and challenges
              • Promotes team work while working through solutions Health care business acumen with a comprehensive understanding of the pharmaceutical industry WHAT TAKEDA CAN OFFER YOU:
                • 401(k) with company match and Annual Retirement Contribution Plan
                • Tuition reimbursement Company match of charitable contributions
                • Health & Wellness programs including onsite flu shots and health screenings
                • Generous time off for vacation and the option to purchase additional vacation days
                • Community Outreach Programs Discover more at

                  Base Salary Range: $160,300 to $229,000, based on candidate professional experience level. Employees may also be eligible for Short Term and Long-Term Incentive benefits as well. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days & Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off.

                  This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy.

                  EEO Statement

                  Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

                  Locations

                  Boston, MA

                  Worker Type

                  Employee
                  Worker Sub-Type

                  Regular
                  Time Type

                  Full time

Keywords: Takeda Pharmaceutical, Weymouth , Trial Operations Data Lead - Alta Petens, Other , Weymouth, Massachusetts

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