Senior Implementation Manager, Sensing and Measurement

Company: Takeda Pharmaceutical
Location: Newark
Posted on: January 26, 2023

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 Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Senior Implementation Manager, Sensing and Measurement. At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Here, you will be a vital contributor to our inspiring, bold mission. The R&D Digital Health Sciences 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, 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 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 device solutions, considering operational and analytical aspects as well as a longer strategic vision of the GPT programs.
• Collaborate with peers within the Digital Heath Sciences 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 digital solutions enabling drug discovery and development
• Support the deployment of digital device solutions to address the GPT needs, enhance the value of the pipeline, and provide a superior experience for the patients
• Support small-scale validation testing of digital 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 the development and operationalization of novel digital biomarkers and endpoints for use in clinical trials
• Assist in the development of a portfolio of digital device requirements by continuously collaborating with internal and external stakeholders
• 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 and data transfer specifications
• 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
• Enhance asset value by supporting digital device strategy, providing operational device assistance during study startup, and managing digital device technologies as part of clinical trial execution/delivery
• Work with GPTs to lead concept design and early execution of digital device solution development
• Participate in key GPT meetings as needed and support up to 5 project teams projects
• Work with full clinical teams to collectively select and implement appropriate technology platforms and digital devices within clinical trials (both early stage and late stage)
• Oversee digital device vendor selection, support SOW negotiations, provide oversight of User Requirements, Data Privacy, and Data Transfer Specifications, and User Acceptability Testing during clinical trial startup phase
• Create site instruction manuals and patient instruction manuals for digital devices
• Oversee digital device vendor timelines and milestones
• Create and maintain technical documentation and oversee Verification and Validation of digital devices
• Contribute to UAT test scripts and oversee the conduct of UAT for digital devices
• Attend SET meetings and oversee maintenance phase of study
• Responsible for monitoring/compliance of digital devices and data during the clinical trial
• Manage or oversee data flow (raw and processed) during study implementation and early execution
• Support 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
• Engage internal and external subject matter experts (eg, 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 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 Minimum Requirements/Qualifications
  • BS/BA degree in a technical discipline with 6+ years of relevant experience, MS with 4+ years, or PhD with 2+ 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 (eg, innovators in academia and startups)
  • Proven experience in learning from failure This position is currently classified as "hybrid" in accordance with Takeda's Hybrid and Remote Work policy.$124,600 to $178,000, 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 posting is made in compliance with Colorado's Equal Pay for Equal Work Act, C.R.S. - 8-5-101 et seq In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.
    • Minimum Requirements/Qualifications 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 Cambridge, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time

Keywords: Takeda Pharmaceutical, Newark , Senior Implementation Manager, Sensing and Measurement, Executive , Newark, New Jersey