Executive Director, Data Management
Company: Daiichi Sankyo
Location: Basking Ridge
Posted on: October 30, 2025
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Job Description:
Join a Legacy of Innovation 125 Years and Counting! Daiichi
Sankyo Group is dedicated to the creation and supply of innovative
pharmaceutical therapies to improve standards of care and address
diversified, unmet medical needs of people globally by leveraging
our world-class science and technology. With more than 125 years of
scientific expertise and a presence in more than 20 countries,
Daiichi Sankyo and its 18,000 employees around the world draw upon
a rich legacy of innovation and a robust pipeline of promising new
medicines to help people. In addition to a strong portfolio of
medicines for cardiovascular diseases, under the Group’s 2025
Vision to become a “Global Pharma Innovator with Competitive
Advantage in Oncology,” Daiichi Sankyo is primarily focused on
providing novel therapies in oncology, as well as other research
areas centered around rare diseases and immune disorders. Summary
The Executive Director, Data Management (Head of Global Data
Management) sets the vision, direction, and strategy for Data
Management globally and ensures execution of the data management
strategy across regions. This individual is responsible for
performance of the function and the development of group members
and also monitors trends in functional performance via quality,
time, and cost indicators, and develops plans and leads the
execution for improvements. Additionally, this individual develops
and executes strategies within the scope of BDM management and in
collaboration with stakeholders that are optimized across business
units, regions, and functional areas to ensure successful outcomes
for projects/studies. This individual has sufficient understanding
of regulations and GCP requirements for drug development, advanced
knowledge of Electronic Data Capture/related applications and
industry standards, and advanced skills partnering with CROs and
other third-party vendors. He/She will have excellent
verbal/written skills, analytical, organizational, and people
management skills and collaborates effectively with stakeholders at
different levels and from different disciplines and cultures.
Additionally, he/she will possess advanced knowledge of clinical
operations and relevant regulatory requirements. The individual
will have advanced experience working on Phase I-IV studies within
the pharmaceutical industry across multiple therapeutic areas and
is capable of leading DM activities to support regulatory
submissions and inspections. Finally, this position has advanced
skills in continuous improvement, project management, change
management, and risk management. Responsibilities Leadership,
Direction, and Strategy: - In collaboration with Clinical
Development and Clinical Operations as well as other BDM functions,
sets the vision, direction, and strategy for Clinical Data
Management globally and ensures execution of the global data
management strategy across regions and across studies/programs. -
Represents Data Management in governance bodies internally and
externally with CRO partners and stakeholders. - Liaises with other
function heads to ensure effective cross-functional collaboration
and proactive communication throughout the drug development
process. - Collaborates within the function and cross-functionally
to resolve issues pertaining to data management in clinical trials
and submissions work. - Proactively identifies and manages risks
for the data management function and supports functional risk
identification/management efforts globally. - Serves as the
internal Data Management expert to provide strategic thinking for
outsourcing strategy. As a member of the CRO governance committee,
provides strategic leadership in Data Management related topics and
establishes the oversight model for timely and quality delivery and
regulatory compliance of outsourced activities. - Ensures
inspection readiness of all data management activities conducted
internally or outsourced Management of the function: - Provides
strong leadership and inspiration to the Data Management function.
Hires, develops, and retains talents. Responsible for the
performance management of the Data Management function, including
performance of outsourced data management activities. - Forecasts
and manages Data Management resources needs, budget and timelines -
Ensures Data Management has the appropriate skills, processes, and
tools to achieve the RD objectives. - Monitors trends in
departmental performance via quality, time, and cost indicators,
and makes recommendations for improvements. - Resolves and/or
escalates issues encountered at the department level. - Provides
the highest level of CRO/vendor oversight to ensure project plans
are executed properly (e.g., operational leadership teams).
Functional Expertise: - Serves as a Data Management expert
accountable for robust RD data management processes (including but
not limited to CRF/eCRF design, all steps from database development
to database release, data review and cleaning, database lock), to
ensure data quality/integrity and regulatory compliance - Ensures
that Data Management Plans are consistent and regulatory compliant
across studies and programs. - Promotes Risk Based approaches to
data cleaning and review - Proactively collaborates
cross-functionally during interactions with Regulatory Authorities
and other key external stakeholders (e.g., advisory committees and
integration teams). - Serves as the Data Management leader
representing RD during regulatory inspections and internal audits
pertaining to RD activities. Operational Efficiency / Continuous
Improvement: - Leads standardization efforts in Data Management and
ensure global implementation. - Promotes automation, innovation,
process improvement and technology enhancement in Data Management
to increase Drug Development efficiency - Provides oversight and
leads the efforts to implement and develop Data Management
processes and tools based on emerging trends, technology, and best
practices. - Leads implementation of improvements and makes
recommendations for regional/global implementation. - Actively
contributes to the review of best practices within the function. -
Maintains peer relationships with thought leaders in Data
Management and related areas. - Leverages Data Management and
related expertise to promote best practices across the Drug
Development lifecycle. Qualifications: Successful candidates will
be able to meet the qualifications below with or without a
reasonable accommodation. Education Qualifications (from an
accredited college or university) - Bachelor's Degree with 15 years
of relevant experience required - Master's Degree with 13 years of
relevant experience preferred Experience Qualifications - Data
management and/or related work experience in a medical device or
pharmaceutical company, or similar environment (e.g., CRO) required
Travel: Ability to travel up to 20% domestic and international
travel Daiichi Sankyo, Inc. is an equal opportunity/affirmative
action employer. Qualified applicants will receive consideration
for employment without regard to sex, gender identity, sexual
orientation, race, color, religion, national origin, disability,
protected veteran status, age, or any other characteristic
protected by law. Salary Range: $258,450.00 - $430,750.00 Download
Our Benefits Summary PDF
Keywords: Daiichi Sankyo, Plainfield , Executive Director, Data Management, Science, Research & Development , Basking Ridge, New Jersey