The R&D Digital Health Sciences group within the Data Sciences Institute leads the development, adoption, and deployment 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, and Information Technology, we take on fundamental challenges such as enabling global decentralized trials, 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 key member of the group at this exciting and transformative time you will:

• Own enhancements to asset strategy through supporting Global Project Teams (GPTs) with design and execution of highest value digital device solutions, considering operational and analytical aspects as well as a longer strategic vision of the GPT programs.

• Inform, optimize, and execute the GPT’s digital strategy to implement digital device solutions within clinical trials or clinical development program

• Support GPTs in the identification, design, and implementation of digital device solutions to address the program’s needs

• Develop a portfolio of digital device requirements by continuously collaborating with peers within Digital Health Sciences, other DSI stakeholders, and internal and external partners (clinical operations, procurement, statistics, technology partners, clinical research organizations, academia)

• Conduct verification, analytical validation, and clinical validation testing on digital devices to determine fit-for-purpose usage in clinical trials

• Identify/create, develop, validate, and operationalize novel digital biomarkers and endpoints for use in clinical trials

• Navigate the landscape of data privacy, specifically focused on regional / geographic considerations

• Design and support data transfer specifications for devices in accordance with geographic requirements and limitation

• Work collaboratively with Therapeutic Area Units (TAUs) leadership, GPTs, digital key opinion leaders (KOLs), Takeda DD&T, and external partners to understand the landscape of digital devices to enable drug discovery and development, drive prioritization of digital needs across R&D (asset level), and design/propose appropriate technology solutions to address these needs, enhance the value of the pipeline, and provide a superior experience for the patients

• Develop a suite of technology tools that can be readily deployed through a deep understanding of their performance characteristics, their operational requirements, their associated data analysis and their potential contexts of use

• Critically evaluate new or existing digital technologies, applications, or platform solutions; identify potential risks and develop mitigation plans for technology integration or deployment in clinical trials

• Educate GPTs, TAUs, and broader R&D organization on digital deployment and agile ways of working to build comfort and drive adoption of digital devices

ACCOUNTABILITIES

• Enhance asset value by owning and driving digital device strategy and early execution/delivery

• Work with GPTs to lead concept design and early execution of digital device solution development

• Work with Clinical Teams to design and implement digital devices within clinical trials (both early stage and late stage)

• Drive the selection of appropriate Digital Devices and assist with their implementation within clinical trials

• Oversee digital device vendor selection and support SOW negotiations, provide oversight of User Requirements, Data Privacy, and Data Transfer Specifications, and User Acceptability Testing

• Conduct end-to-end verification, analytical validation, and clinical validation testing on digital devices to determine fit-for-purpose usage in clinical trials

• Identify/create, develop, validate, and operationalize novel digital biomarkers and endpoints for use in clinical trials

• Provide region-specific guidance in accordance with local medical and digital device and IT regulations with a focus on data integrity, privacy, and security

• Partner with TAU leadership to jointly prioritize programs that would benefit most from digital device solutions

• Engage internal and external subject matter experts (e.g., digital KOLs, patients, academia) to refine approach to solving unmet needs and to design/identify optimal digital device solutions to enhance asset value

• Work with peers within Digital Health Sciences to develop portfolio view of device needs and asset-level solutions

• Partner closely with Data Architecture and Takeda DD&T to enable common prioritization of complex R&D digital deliverables

• Collaborate with Takeda Center for External Innovation (CEI), Takeda DD&T, DSI colleagues and external partners to collectively select appropriate technology platforms and vendors for efficient solution development and deployment

• Participate in key GPT meetings as needed and manage 6-8 projects, up-to 3 concurrently

• Partner with R&D leadership to identify platforms and opportunities for scalable experiential digital learning (to build comfort with digital concepts and approach)

• Maintain and expand a network of internal and external partners to facilitate technology implementation (devices, applications, platform solutions), data collection, analysis, and interpretation in clinical trials

• Work with internal and external partners to monitor the ecosystem for emerging technologies and novel biomarkers, measurement techniques, or data sources, and critically evaluate these technologies, providing recommendations for implementation

DIMENSIONS AND ASPECTS

• Broad understanding of the pharmaceutical industry; deep understanding of pharmaceutical and medical device clinical development processes, timing, interdependencies, regulatory, privacy, and ethics

• Extensive hands-on experience with all aspects of designing and deploying digital devices in global clinical trials required (identification, operationalization, and analysis)

• Willingness to experiment, implement, learn, and teach

• Digital literacy and ability to drive change pragmatically using novel technologies

• Understanding of programming principles, tech development, data analytics/data science, and data management process

• Engineering, physics, or science background with proven record of designing and executing controlled experiments with digital/medical devices and critically interpreting the experimental data is highly desirable

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

• BS/BA degree in a technical discipline with 10+ years of relevant experience, MS with 8+ years, or PhD with 6+ years required (MS, Ph.D. or equivalent advanced degree in 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)

• Proven experience in learning from failure