Senior Implementation Manager, Sensing and Measurement
Company: Takeda Pharmaceutical
Location: Cherry Hill
Posted on: January 15, 2023
Job Description:
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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 (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 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
(e.g., 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, Cherry Hill , Senior Implementation Manager, Sensing and Measurement, Executive , Cherry Hill, New Jersey
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