Research & Development, LLC, a member the Janssen Pharmaceutical Companies
of Johnson & Johnson is recruiting for a Head, Clinical Development
Standards to be located at the Janssen campuses on the East Coast US (Titusville NJ, Raritan, NJ or
Springhouse, PA applicable) OR Beerse, Belgium.
Pharmaceutical Companies of Johnson & Johnson are dedicated to addressing
and solving some of the most important unmet medical needs of our time in
oncology, immunology, neuroscience, infectious diseases and vaccines, and
cardiovascular and metabolic diseases.
Driven by our commitment to patients, we bring innovative products,
services and solutions to people throughout the world. We recognize the impact
of serious conditions on people's lives, and we aim to empower people through
disease awareness, education and access to quality care. Our research and development strategy focuses
on identifying medical needs and harnessing the best science in the world,
whether from our own laboratories or through strategic relationships and
collaborations. We leverage our world-class discovery and development expertise
and operational excellence to deliver innovative, effective solutions.
to the Head of Integrated Data Analytics & Reporting (IDAR), the job holder
is accountable for leading all aspects of clinical development standards from
collection to reporting. With a predominant focus on scientific, strategic and
technical leadership, the Head, Clinical Development Standards will translate
the standards strategy into a robust implementation plan, executing against the
plan globally, and monitoring success through metrics and a robust governance
that end, the job holder will work across the organization and partner with
relevant departments in Global Clinical Development Operations (GCDO) and
outside GCDO such as, but not limited to, the various Therapeutic Areas,
Quantitative Sciences and Regulatory Affairs. Additionally, the job holder will
partner in cross sector initiatives pertaining to the wider implementation of
clinical development standards.
job holder will provide oversight and leadership to the Clinical Development
Standards team, driving the enablement of efficient business processes through
Head, Clinical Development Standards will be responsible for leading a team in
IDAR that is accountable for developing, deploying and maintaining Clinical
Development Standards in support of the Janssen pharmaceutical portfolio of
products specifically within Janssen R&D scope, driving data quality and
consistency within and across line functions.
Head, Clinical Development Standards will champion development and
implementation of Clinical Development Standards, ensuring effective
communication and collaboration among standards and other functional groups
utilizing standards. This includes but not limited to training on new
standards, impact analysis of changes in standards, including the impact on
a strong background in at least one of the disciplines of data management,
statistical reporting and analysis, the job holder will be conversant in the
latest technologies supporting Clinical Development Standards. Additionally,
the job holder will be an expert in Pharmaceutical Industry Standards such as
the Clinical Data Interchange Standards Consortium (CDISC), Study Data
Tabulation Model (SDTM) and Analysis Data Model (ADaM) as well as associated
case report tabulations data definitions (Define-XML) for submission to
job holder will be accountable for the scientific correctness of all standards
supporting data management, programming, statistical analysis and regulatory
job holder will have proven leadership experience in broad scale deployment of
end-to-end standards and demonstration of business value in terms of increased
compliance and reduction in cycle time and cost. In support of driving business
value related to investment in Clinical Development Standards, the job holder
will ensure the relevant metrics covering development, maintenance; adoption
and associated value (time, cost, quality & customer) are in place.
- To ensure his/her team are delivering business
value on an ongoing basis, the job holder will be responsible to create a
continuous improvement framework with respect to Clinical Development Standards
and the implementation thereof supported by greater partnerships with internal
business partners, suppliers, CRO partners and industry user groups.
the job holder will initiate and lead business process changes within the
context of data standardization and in collaboration with other partner
functions as required.
job holder will lead the Governance to enforce Janssen’s Global Clinical
Development Standards strategy, ensuring adherence, balanced vis-à-vis the
needs of clinical development to deliver the highest business value.
job holder will be a member of the IDAR leadership team contributing to the
overall IDAR strategy and the successful execution of annual goals and
objectives of the IDAR team in line with GCDO and RDO imperatives. The job
holder will provide regular updates and insights to the IDAR leadership team on
the status of Clinical Development Standards, highlighting operational or
scientific roadblocks and proposing potential solutions that will assist in
removing the roadblocks.
job holder will be responsible for establishing an internal and external
benchmarking network facilitating the distillation of best practices from
leading organizations externally whilst also identifying best practices from
internal teams within J&J.
position reports to Head IDAR. The job holder will be expected to provide
leadership to the Clinical Development Standards team by attracting and
retaining top talent, developing team members, and ensuring organizational
effectiveness, transparency, and communication.
position is responsible for a team of more than 30 Janssen Employees globally,
in addition to necessary contract and flex support based on portfolio and
degree is required.
advanced degree (e.g. Masters, MBA, MD, PhD) is preferred.
years of experience in the Pharmaceutical Clinical Development industry is
years of experience in a senior managerial position leading people is required.
expertise in CDISC, ADaM and SDTM standards is required.
expertise in at least one of the disciplines of data management, statistical
reporting and analysis is required.
thorough understanding of clinical research processes is required, with
demonstrated expertise in deploying Clinical Development Standards supported by
technology is required.
to thrive in a global multicultural matrix environment is required
to manage high workload and critical issues in a timely manner is required
of HL7 standards is preferred.
position requires up to 25% travel both domestic and international.
Johnson is an equal opportunity employer
United States-Pennsylvania-Spring HouseOther Locations
North America-United States-New Jersey-Titusville, North America-United States-New Jersey-Raritan, Europe/Middle East/Africa-Belgium-Antwerp-BeerseOrganization
Janssen Research & Development, LLC. (6084)Job Function
Clinical Data ManagementRequisition ID