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Job Description

At Takeda, we are a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. By focusing R&D efforts on four therapeutic areas and other targeted investments, we push the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.

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)
• 
  Proven experience in learning from failure

What Takeda can offer you:

• Comprehensive Healthcare: Medical, Dental, and Vision
• Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
• 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 and company match of charitable contributions
• Family Planning Support
• Flexible Work Paths
• Tuition reimbursement

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

This position is currently classified as “hybrid” in accordance with Takeda’s Hybrid and Remote Work policy.

Base Salary Range:, $101,500- $145,000 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.

In accordance with the CO Equal Pay Act, Colorado Applicants Are Not Permitted to Apply.

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