Job Summary
The 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 Associate 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 Associate 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 Description
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Collaborates by providing strong input with business leaders to develop a develops strategies and plan for building clinical analytics capabilities and data review across CM and R&D portfolio based on critical priorities of the R&D Business.
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Build and support GCI as a “center of excellence” to support traceable and data (metric) biased informed decision making.
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Support GCI Leadership to ensure oversight, coordination and development of clinical trial operations analytics (e.g., trial feasibility analysis, geography, site selection, smart metrics, analytical insight and actionable recommendations).
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Provides guidance on and coordinate training to teach functional area personnel the fundamentals of big data and clinical data review.
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Strategizes, develops and implements innovative, intelligent-smart metrics, analytical insight, and actionable recommendations and data driven approaches and strong 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.
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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.
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Plays an active role in knowledge sharing and metric analytical capability building throughout Clinical Management, Strategic Sourcing and Applied Innovation and Process Improvement functions.
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Provides people leadership to the GCI group –priority and objective setting, people development, etc.
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Leads at the intersection of data, science and operations –develops measures of success metrics from performance to ROIs.
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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.
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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.
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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.
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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
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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 trials.
Qualifications/ Required
Knowledge/ Experience and Skills:
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A minimum of 6 years of applicable health care, clinical or industry experience required.
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Strong analytic skills and familiarity with the drug development and regulatory process. Familiarity with standard tools and databases for clinical operations in the industry.
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Successful demonstration of leadership and timely delivery of innovative business deliverables.
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Good 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.
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Good understanding of technological trends and passion to develop innovative solutions that support and enhance medicine, science, and research to increase Otsuka’s competitive edge.
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Ability to work self-guided with guidance effectively in a matrixed, multi-cultural, collaborative and self-directed environment.
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Good project management experience, with the ability to successfully engage in multiple initiatives simultaneously.
Educational Qualifications
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BS, MS
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Come discover more about Otsuka and our benefit offerings;
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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 Accommodation
The 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.
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