Senior Implementation Manager, Sensing and Measurement
Company: Takeda Pharmaceutical
Location: Newark
Posted on: January 26, 2023
Job Description:
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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
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