Associate Director, Clinical Solutions Product Lead
Otsuka Pharmaceutical

Job Info

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The Associate Director, Clinical Solutions Product Lead will have overall responsibility for the clinical suite of applications and will serve as the Solution Strategist, Solutions Implementation Technical Lead, and Solution Support lead for these applications. In this position, the Lead will engage with a cross functional array of functional departments, OIT (Otsuka IT) groups, offshore manage service providers, and software vendors to deliver on a global eSolutions platform strategy that will transform Clinical Trial Operations at Otsuka.

The Lead will gain an understanding Otsuka's strategic drivers and tactical needs to provide technically innovative solutions that meet the business needs with the necessary usability, technical stability, and scalability.

Responsibilities include:

• Solution Strategist
  • Plan and develop the Architectural Runway in support of new business Features and Capabilities.
  • Produce information flows, architecture, technology roadmaps and technical implementation blueprints in close alignment with business capability roadmaps.
  • Review, analyze, evaluate new opportunities to improve, develop or integrate new technical capabilities into the R&D Clinical Management, Clinical Data management, Bio statistics, Biometrics and the overall operations in the area of clinical trials and associated eco-systems.
  • Ensure solutions being developed, takes global needs into accounts, architecturally flexible to extend to related business areas and affiliates ensuring maintainability and supportability of systems and are enterprise grade. Support projects and operational activities in the eClinical ecosystem.
  • Partner with business information manager to manage the e-solutions strategic roadmaps and provide investment recommendations.
  • Provide leadership to ensure that capabilities delivered align with original business objectives, application service levels, IT strategies, and design intent.
  • Synthesize and communicate complex technical and business information easily to senior management and business stakeholders.
  • Actively participates in Architecture Community of Practice internally and/or externally (industry forums, vendors etc.)
• Solution Implementation technical lead
  • Create and manage project plans and timelines, define project deliverables, assign project team roles and resources, identify and track issues and their resolution, and manage project scope and requirements.
  • Drive the System Life cycle process through requirements, architecture, Design, Testing & Deviation Management, and the needed GxP Validation Process.
  • Actively seeks and drives opportunities for continuous improvement of applications, during team's project work and for internal processes.
  • Create and own the Solution Architecture documentation and works closely with the technical team to monitor technical development of solutions; configures the system when necessary.
  • Ensure that Solutions are technically/ architecturally consistent, fit for purpose, meet customer requirements, and comply with all relevant IT and business standards such as reuse of technologies and solutions, and simplicity and usability.
  • Help bridge the gaps and hand-offs issues between requirements / functional resources, development teams, and project leadership / sponsorship.
• Solution Support
  • Manage the MSP team to successfully maintain systems and exceed performance SLAs
  • Actively seeks and drives opportunities for continuous improvement of applications, during team's project work and for internal processes.
  • Ensure support of key business processes and appropriate levels of integration / automation.

QUALIFICATIONS:

• Strong written and verbal communications skills proven by working with cross functional and global teams.
• Experience managing offshore teams.
• A minimum of 10 years working within a Pharmaceutical environment with strong understanding of drug development process, global regulatory environment and eSolution technologies (eConsent, RBM, eSource, Central and Remote Data Review, eTMF, Oracle's LSH and SAS) and running these technologies in the Cloud (preferably AWS)

• Minimum of a bachelor's degree (BS/BA) in either Comp Science, engineering, or scientific degree.
• Experience in Agile methodologies, Project Management, IT SDLC and DevOps framework
• Experience with Analytics and BI (Tableau or similar tool) is highly preferred.

• Experience and creating, evaluating, recommending business cases in addition to developing business and technical value realization framework.
• Proven experience in Operational Excellence - including but not limited to Continuous Improvement, Project and/ or Technical Management, Change Management methodology, financial/budget and contract management.
• Hands-on experience in applying architectural principles, methods, and tools to business challenges by assimilating and correlating disconnected sets of information and articulate their collective relevance to the organization and to high-priority business issues.

Additional Requirements:

• Travel Requirements. 15 - 20%

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.

Equal Opportunity Employer

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.

Come discover more about Otsuka and our benefit offerings; https://www.otsuka-us.com/careers-join-otsuka.

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.

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