Head of Clinical Data Strategy (BOSTON)
Company: Takeda Pharmaceutical
Location: Boston
Posted on: March 25, 2026
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Job Description:
By clicking the “Apply” button, I understand that my employment
application process with Takeda will commence and that the
information I provide in my application will be processed in line
with Takeda’s Privacy Notice and Terms of Use. I further attest
that all information I submit in my employment application is true
to the best of my knowledge. Job Description OBJECTIVES/PURPOSE -
Responsible for driving the strategy for Takeda’s global data
standards, processes, and technologies across the clinical data
continuum for quality of deliverables and global data
interoperability. - Actively participates in and influences Data
Standards forums (internally or externally) to maintain awareness
of any initiatives and trends that could be incorporated into or
enhance Takeda's Therapeutic Area Clinical Data Standards Library.
- Supports enforcement of Takeda's Global Data Standards Governance
to ensure proper utilization of standards, adherence to standards
processes, and the timely, thorough assessment of library
enhancements and deviations. - Actively leads the identification,
review/evaluation, deployment and usage of technologies to
generate, distribute, and/or integrate with and report on standards
compliance internally, and manages in-house programs along with
standards vendor(s) to support Standards Management vision. -
Builds relationships across the global Takeda organization and with
CROs/strategic service providers, provides project management
leadership of standards projects and has the ability to partner
closely with internal/external standards stakeholders, and serves
as a resource to support questions raised by regulatory agencies.
ACCOUNTABILITIES - In collaboration with the Cross-functional SET
and TAU Leaders, establishes and drives strategy of Takeda’s global
data standards, processes, and technologies across the clinical
data continuum ensuring quality of deliverables and global data
interoperability. - Develops the standards library (e.g., Veeva
CDMS, Edit Checks, DTS, eCOA, IRT, CDISC, ADaM, TLFs) and ensures
proper utilization of standards, adherence to all standards
processes, and the timely, thorough assessment of library
enhancements and deviations through Standards Governance. - Builds
relationships across the global Takeda organization and CRO
partners in support of the standards vision and implementation. -
Has advanced knowledge of all standard library components and
metadata across data collection, analysis, and reporting continuum
and serves as a resource to support questions raised by regulatory
agencies. - Has a demonstrated understanding of clinical data
capture/management systems, clinical databases, data flow, and
related infrastructure, with experience in/around EDC, EHR, eCOA,
IRT, CDR, MDR, SCE and adjacent systems. - Has strong working
knowledge of clinical study processes and related regulatory
requirements or information governance frameworks, (e.g., 21 CFR
Parts 11, 312, 314, Good Clinical Practice [ICH-GCP E6 R2], Good
Clinical Data Management Practices, HIPAA, GDPR, etc.). -
Supervises staff and vendors developing standards library elements
to ensure alignment to standards strategy. Develops training
strategy and ensures consistent training program for standards. -
Oversees Standards Governance, manages deviations from standards
content and processes, conducts periodic review and development of
various metrics including assessment of standards utilization and
development trends. - Drives ongoing development and improvement of
industry standards and provides leadership to external professional
activities and organizations, such as CDISC, Phuse, Transcelerate,
SCDM, EDC users group, SAS users group, etc. - Actively
communicates and ensures compliance with submission standards and
guidance documents, regulatory agency expectations and industry
trends as applicable to the Takeda organization. Actively
participates and contributes at industry standards forums in
support of Takeda’s assets. CORE ELEMENTS RELATED TO THIS ROLE -
Leads a team to effectively govern and build standards library,
align with leadership on operational strategy and engage
stakeholders. - Thorough knowledge and understanding of standards
development processes, focused on clinical data with a strong
knowledge of CDISC, HL7, OMOP, ICH, ISO standards and an
understanding of global privacy regulations. - Proven track record
in development and management of standards library and in-depth
knowledge of study design through submission EDUCATION, BEHAVIOURAL
COMPETENCIES AND SKILLS: - BS/BA or MS in a life science or
analytical area with over 12 years of experience in a
CRO/pharmaceutical environment with a proven and consistent record
of proactive management and innovation. - Minimum 12 years of
clinical data management and/or database or statistical programming
experience in pharmaceutical industry or health related field. -
Thorough knowledge and understanding of standards development
processes, focused on clinical data with a strong knowledge of
CDISC, HL7, OMOP, ICH, ISO standards and an understanding of global
privacy regulations. - Proven track record for development and
management of standards library in addition to in-depth knowledge
of study design implementation, to define standards eCRFs, edit
checks, best practices in EDC and other data acquisition sources. -
knowledge of statistical programming languages (e.g., SAS, R,
Python, etc.). - Desirable CDM technical expertise (e.g., EDC Veeva
and/or Rave, elluminate). - Expertise in the requirements and
technology required to support electronic data capture and
electronic submissions. - Proven track record in identifying and
implementing organization-wide initiatives, standards, and
processes. - Proven track record in managing global,
cross-functional standards and processes, support a culture of
continual improvement and innovation; promotes knowledge sharing. -
Excellent teamwork, organizational, interpersonal, conflict
resolution and problem-solving skills. - Entrepreneurial and
innovative; takes measured risks; thinks outside the box;
challenges the status quo. - Pragmatic and willing to drive and
support change and comfortable with ambiguity. - Direct experience
in the pharmaceutical industry or related field required. -
Previous experience leading a medium to large organization and
influencing senior-level management and key stakeholders. - Proven
track record of leading and driving business process transformation
and organizational culture change as well as delivering programs
with complex business deliverables. - Track record of successful
leadership, management, and development of large,
multi-disciplinary globally dispersed teams. Strong judge of talent
with the ability to make tough talent decisions. - Health care
business acumen with a comprehensive understanding of the
pharmaceutical industry. This position is currently classified as
“remote” by Takeda’s Hybrid and Remote Work policy Takeda
Compensation and Benefits Summary We understand compensation is an
important factor as you consider the next step in your career. We
are committed to equitable pay for all employees, and we strive to
be more transparent with our pay practices. For Location:
Massachusetts - Virtual U.S. Base Salary Range: $174,500.00 -
$274,230.00 The estimated salary range reflects an anticipated
range for this position. The actual base salary offered may depend
on a variety of factors, including the qualifications of the
individual applicant for the position, years of relevant
experience, specific and unique skills, level of education
attained, certifications or other professional licenses held, and
the location in which the applicant lives and/or from which they
will be performing the job. The actual base salary offered will be
in accordance with state or local minimum wage requirements for the
job location. U.S. based employees may be eligible for short-term
and/ or long-term incentives. U.S. based employees may be eligible
to participate in medical, dental, vision insurance, a 401(k) plan
and company match, short-term and long-term disability coverage,
basic life insurance, a tuition reimbursement program, paid
volunteer time off, company holidays, and well-being benefits,
among others. U.S. based employees are also eligible to receive,
per calendar year, up to 80 hours of sick time, and new hires are
eligible to accrue up to 120 hours of paid vacation.
Keywords: Takeda Pharmaceutical, Brockton , Head of Clinical Data Strategy (BOSTON), Executive , Boston, Massachusetts
