Associate Director/Director, Sensing and Measurement
Company: Takeda Pharmaceutical
Location: Cambridge
Posted on: January 26, 2023
Job Description:
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to the best of my knowledge. Job Description Takeda Pharmaceutical
About the role: 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 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. How you will
contribute:
- 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 IT,
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
- 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 (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 peers within Digital Health Sciences to develop
portfolio view of device needs and asset-level solutions
- Partner closely with Data Architecture and Takeda IT to enable
common prioritization of complex R&D digital deliverables
- Collaborate with Takeda Center for External Innovation (CEI),
Takeda IT, 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
Minimum Requirements/Qualifications:
- 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 (eg,
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 More about us: 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: $137,200 to $196,000 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 Cambridge, MA Worker Type Employee Worker Sub-Type
Regular Time Type Full time
Keywords: Takeda Pharmaceutical, Cambridge , Associate Director/Director, Sensing and Measurement, Executive , Cambridge, Massachusetts
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