Director, Operational & Systems Excellence
Company: Takeda Pharmaceutical
Posted on: May 13, 2022
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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.
Join Takeda as a Director, Operational & Systems Excellence where
you will lead a team that works across Global Medical Affairs (GMA)
Therapeutic Areas (TA) and functions ensuring high-quality
deliverables. You will also ensure a consistent process and quality
for evidence generation operations is implemented across all
therapeutic areas (TA). - Oversee administration and proper use of
GMA-related research IT system/digital applications, such as
iEenvision, CTMS, Nexus, FMV tools, and ensures compliance by
collaborating with the appropriate internal partners. - Partner
with Business Solutions & Analytics to provide information to the
business such as metrics and KPIs. - You will partner with the
regions for training and disseminating evidence generation
operational excellence, which includes best practice sharing. -
Support the development of evidence generation policies and SOP
trainings. - As part of Global Medical Evidence, you will report to
Head, Global Medical Evidence and work with the Global Medical
How you will contribute: Oversees the development, implementation,
administration and proper use of processes, systems and tools to
enable efficient and compliant delivery, tracking, reporting and
communication of Takeda Medical Affairs evidence generation.
Facilitates alignment with other business functions within the
organization, particularly the GPTs, Regions/BUs and R&D to
ensure consistency in understanding and implementing of asset level
research and data standards.
Oversees processes, systems and activities related to data curation
and generation from a variety of internal and external sources to
ensure data are centrally maintained, managed and available for
stakeholders to access in real-time.
Supports evidence generation planning and excellence by development
and implementation of tools, innovative approaches and
collaborations with other business functions.
Support strategies and activities to ensure best practices are
maintained across evidence generation and integration activities
across TAs and Global, Regional and LOC Medical Affairs Units.
Participate as a research functional expert on cross-functional
Ensure support is provided to audits and inspections as applicable
to medical evidence generation related IT systems/digital
application and processes.
Deep understanding of regulations for real-world data in USA,
Europe and RoW
Comprehensive understanding of the pharmaceutical industry and
Global regulatory expertise with demonstrated ability for
collaboration and team leadership; experience leading and working
with cross-cultural teams.
What you bring to Takeda: An advanced degree in a health sciences
related field is required, with PharmD, PhD or MD, or geographic
8 or more years in Medical Affairs, Clinical Research within a
biopharmaceutical industry setting.
Experience leading teams in Medical Evidence Generation
An understanding of research methodology and its application to
medical research planning.
Experience with the key regulations worldwide governing research in
Superior communication, strategic, interpersonal and negotiating
Proactively predict issues and solve problems
Drive decision-making within a multi-disciplinary, multi-regional,
Diplomacy and positive influencing abilities
Ability to drive or fly to various internal and external
Required travel approximately (10 - 20%), including international
trips, overnight stays, and some weekend commitments.
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
Generous time off for vacation and the option to purchase
additional vacation days
Community Outreach Programs and company match of charitable
Family Planning Support
Flexible Work Paths
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
This position is currently classified as "hybrid" in accordance
with Takeda's Hybrid and Remote Work policy
In accordance with the CO Equal Pay Act, Colorado Applicants Are
Not Permitted to Apply.
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.
Keywords: Takeda Pharmaceutical, Clifton , Director, Operational & Systems Excellence, Executive , Teterboro, New Jersey
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