Director Global Clinical Intelligence
Company: Otsuka Pharmaceutical
Location: Rockville
Posted on: January 20, 2023
Job Description:
The Director of Global Clinical Intelligence requires a hands-on
approach with the ability to contribute and influence key
stakeholders at both the operational and executive levels of
Otsuka. The focus of this position is the development of decision
driving intelligent business metrics specific to study operations
and site performance (i.e., sites, suppliers, etc.) using
early-scientific trial concepts, historical strategies and
performance information, external - public and private information
sources (ex. literature searches CT.gov, etc.) and portfolio wide
internal operational data.Position SummaryThe Global Clinical
Intelligence (GCI) Team within Clinical Management is responsible
for driving business via intelligent (smart) metrics, boosting
Otsuka's competitive advantage through actionable and traceable
clinical decisions, and developing strategic relationships
internally and externally. The GCI team is charged with developing
and applying Otsuka-specific clinical intelligent (smart) metric
driven decision-making process to enable informed metric driven
decisions on operational aspects e.g. site selection, study
allocation (ex., geo locations) and program execution to improve
probability of R&D success and the quality of trial operations.
Additionally, the GCI team measures the effectiveness of strategic
and performance decisions to ensure maximum ROI to Otsuka and for
continuous improvements feedback.The Director of Global Clinical
Intelligence requires a hands-on approach with the ability to
contribute and influence key stakeholders at both the operational
and executive levels of Otsuka. The focus of this position is the
development of decision driving intelligent business metrics
specific to study operations and site performance (i.e., sites,
suppliers, etc.) using early-scientific trial concepts, historical
strategies and performance information, external - public and
private information sources (ex. literature searches CT.gov, etc.)
and portfolio wide internal operational data. The role is
responsible for defining the technologies and data needed - as well
as standards for such, and lead decision metric analysts in the
independent review of clinical service providers (CRO) proposals,
trial feasibility, providing enrollment and decision analysis
considerations, risk assumptions and remediation decision
considerations, and competitive analysis.The Director serves as a
key liaison to functional leaders and their business units -
primarily Clinical Management, Global Clinical Development,
Business Development, PV, Pharmacology, Data & Analytics (Clinical
Data Management and Data Clinical Analytics). This position
facilitates the reporting between groups to deliver successful
trial outcomes. Job ResponsibilitiesKey job responsibility
- Contribute to and support the GCI strategy as a "center of
excellence" to support traceable and data (metric) biased informed
decision making.
- Server as a key leader of the GCI and CM organization, to
ensure oversight, coordination and development of clinical trial
operations analytics (e.g., trial feasibility/modeling analysis,
geography and site selection).
- Strategizes, develops and implements innovative, intelligent -
smart metrics, analytical insight, and actionable recommendations
and data driven approaches and advanced methodologies for both
current and planned portfolio of studies, feasibility, site
selection, diversity and inclusion in recruitment, etc., to achieve
rapid startup and trial completion.
- Coordinates with appropriate clinical trial and operational
team leads to execute the process and implementation of the CGI
group, to include a continuous improved decision-making loop.
- Plays an active role in knowledge sharing and metric analytical
capability building throughout Clinical Management, Strategic
Sourcing and Applied Innovation and Process Improvement functions.
- Provides people leadership to the GCI group - priority and
objective setting, people development, etc.
- Leads at the intersection of data, science and operations -
develops measures of success metrics from performance to ROIs .
- Provide leadership and support on pilots, prototypes, and in
beta testing that validate and explore ideas to improve how Otsuka
conducts and improves its general R&D business.
- Promote positive organizational change by way of a serving as a
change agent to ensure successful engagement of teams and the
deliverable of initiatives on time and on budget.
- Identify areas for employing, building and driving improvements
in internal and external communication, leveraging lessons learned
and applying technology solutions to establish cutting edge
practices, e.g. automation, machine learning and artificial
intelligence.
- Support driving "Outside-In" and creative thinking, coordinate
engagements with external innovation companies/consultancies,
promote and further strengthen relationships with investigative
sites, lead efforts to increase patient recruitment, retention and
compliance, and actively lead cross-functional pilots/prototypes;
and play a leadership role in transitioning pilots/prototypes to
full-scale projects
- Leverage advanced solutions and contribute to the business
results as defined in Corporate Goals and supports the
implementation of innovative approaches in the day to day execution
of clinical trialsKnowledge, Skills, Competencies, Education, and
ExperienceAdvance degree and a minimum of 5 years of applicable
health care, clinical or industry experience required.Advanced
analytic skills and general understanding of the drug development
and regulatory process.Successful track record of leadership and
timely delivery of innovative business deliverables.Strong
communication, interpersonal and alliance management skills;
possessing the ability to credibly, knowledgeably and effectively
represent and communicate initiatives to internal and external
KOLs/stakeholders, various stakeholders in the medical/healthcare
community, Otsuka's partners and clinical trial
personnel.Understanding of technological trends and passion to
develop innovative solutions that support and enhance medicine,
science, and research to increase Otsuka's competitive edge.Ability
to work effectively in a matrixed, multi-cultural, collaborative
and self-directed environment.Strong project management experience,
with the ability to successfully engage in multiple initiatives
simultaneously.Physical Demands and Work EnvironmentTravel
(approximately 10-25%)Come discover more about Otsuka and our
benefit offerings;.Disclaimer:This job description is intended to
describe the general nature and level of the work being performed
by the people assigned to this position. It is not intended to
include every job duty and responsibility specific to the position.
Otsuka reserves the right to amend and change responsibilities to
meet business and organizational needs as necessary.Otsuka is an
equal opportunity employer. All qualified applicants are encouraged
to apply and will receive consideration for employment without
regard to their protected veteran or disabled status, or any
protected status.Valid Proof of COVID-19 Vaccination or
AccommodationThe COVID-19 Vaccination is mandatory for incoming new
hires and employees. Uploading documentation with proof of full
vaccination record or an Otsuka approved accommodation will be
required during the pre-employment process as permitted by law. New
hires must be fully vaccinated unless there is an approved
accommodation prior to start date.Statement Regarding Job
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your personal information very seriously. Please be aware
individuals may approach you and falsely present themselves as our
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try to gain access to your personal information or acquire money
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for financial information of any kind or for payment of money
during the job application process. We do not require any
financial, credit card or bank account information and/or any
payment of any kind to be considered for employment. We will also
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this is not Otsuka. These claims are fraudulent and you are
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with Otsuka through its official Otsuka Career website .Otsuka will
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Keywords: Otsuka Pharmaceutical, Rockville , Director Global Clinical Intelligence, Executive , Rockville, Maryland
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