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Job Description
The R&D Digital Strategy Group within the Data Sciences Institute leads the development and adoption of digital health tools within our clinical programs. We are progressive thinkers who leverage decentralized trial platforms, digital measurement technologies, and pioneering research to help deliver life-changing medicines to patients. Together with our colleagues across R&D, Commercial, Information Technology and Takeda’s Digital Advisory Board we take on fundamental challenges such as the development of novel endpoints, the discovery of new digital biomarkers, and the design of digital companions, culminating in a reduction of patients’ burden and improvement of their quality of life.
As a member of the group at this exciting and transformative time you will:
Support Global Project Teams (GPTs) with design and execution of highest value digital solutions in collaboration with Digital Strategy peers, considering operational and analytical aspects as well as a longer strategic vision of the GPT programs
Collaborate with peers within Digital Strategy Group and other DSI stakeholders as well internal and external partners (clinical operations, procurement, statistics, technology partners, clinical research organizations, academia)
Work with Therapeutic Area Unit (TAU) members, GPTs, digital key opinion leaders (KOLs), Takeda IT, and external partners to understand landscape of solutions enabling drug discovery and development
Support the deployment of tech solutions to address the GPT needs and enhance the value of the pipeline and provide superior experience for the patients
Support small-scale validation testing on technology tools that can be deployed in clinical trials to gain a deep understanding of their performance characteristics, their operational requirements, their associated data analysis and their potential contexts of use
Support critical evaluation of new or existing digital technologies, applications, or platform solutions; identify potential risks and develop mitigation plans for technology integration or deployment in clinical trials
Own the development of technical documentation, specifically within Validation and Verification (V&V) of digital technologies
Educate GPTs, TAUs, and broader R&D organization on digital deployment and agile ways of working to build comfort and drive adoption of digital strategies
ACCOUNTABILITIES
Enhances asset value by supporting digital strategy, provides operational assistance during study startup, and manages digital technologies as part of clinical trial execution/delivery
Responsible for monitoring / compliance of digital devices and data within a clinical trial
Collaborates with Takeda Clinical Operations, Data Management, Takeda IT, Digital Advisory Board, DSI colleagues and external partners to collectively select appropriate technology platforms and vendors for efficient solution development and deployment
Attends key GPT meetings as needed and supports up to 5 project teams
Assists in vendor Statement of Work (SOW) negotiations
Creates site instruction manuals and patient instruction manuals for devices
Oversees vendor timelines and milestones
Creates and maintains technical documentation and oversees Verification and Validation of digital devices
Creates UAT test scripts in collaboration with CIO and oversees the conduct of UAT
Attends SET meetings and oversees maintenance phase of study
Manages or oversees data flow (raw and processed) during study execution
EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:
BS/BA degree with 6+ years of relevant experience, MS with 4+ years or PhD with 2+ years required (MS, MBA, Ph.D. or equivalent advanced degree preferred).
Proven track record of delivering on programs with complex business needs
Operational experience in pharmaceutical drug development or medical device development with some exposure to clinical development
Health care business acumen with a basic understanding of the pharmaceutical industry
Self-directed with eternal curiosity and desire to learn
Strong external network in innovative digital technologies (e.g., innovators in academia and startups)
