Executive Director, Data Management
Location: Basking Ridge
Posted on: June 23, 2025
|
|
|
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. Job
Summary: Position sets the vision, direction, and strategy for Data
Management globally and ensures execution of the data management
strategy across regions. This position is responsible for
performance of the function and the development of group members.
This position also monitors trends in functional performance via
quality, time, and cost indicators, and develops plans and leads
the execution for improvements. Additionally, this position
develops and executes strategies within the scope of BDM management
and in collaboration stakeholders that are optimized across
business units, regions, and functional areas to ensure successful
outcomes for projects/studies. This position 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. This position has
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, this position possesses advanced knowledge
of clinical operations and relevant regulatory requirements. This
position has 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. Lead DM
resource model internalization for both strategy and implementation
in terms of infrastructure, processes/ standards, internal
talents/expertise/leadership, and resource planning and management.
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 R&D
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 R&D 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 R&D
during regulatory inspections and internal audits pertaining to
R&D 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: To perform this job successfully, an
individual must be able to perform each essential duty
satisfactorily. The requirements listed below are representative of
the knowledge, skill, and/or ability required. Reasonable
accommodations may be made to enable individuals with disabilities
to perform the essential functions. Education and Experience:
Bachelor's Degree with 15 years of relevant experience required
Master's Degree with 13 years of relevant experience preferred Data
management and/or related work experience in a medical device or
pharmaceutical company, or similar environment (e.g., CRO) required
Travel Requirements: Ability to travel up to 20%, domestic and
international travel This Job Profile is a summary of the
position's responsibilities and required qualifications at the
point in time at which it was created. However, responsibilities at
a growing organization such as ours are dynamic. This Job Profile
may not accurately reflect future responsibilities and
accountabilities associated with this position. This description is
based on management’s assessment of the requirements and functions
of the job of the date this description was prepared. It is a
general guideline for managers and colleagues, but it does not
purport to be an exhaustive list of all the elements of the job.
Management reserves the right on a temporary or indefinite basis to
change or adjust job requirements to meet business, scheduling and
staffing needs. 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.
Keywords: , Danbury , Executive Director, Data Management, Science, Research & Development , Basking Ridge, Connecticut
