Otsuka Pharmaceutical Company is a global healthcare company with the corporate philosophy: "Otsuka-people creating new products for better health worldwide." Otsuka researches, develops, manufactures and markets innovative products, with a focus on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health.
In pharmaceuticals, Otsuka is a leader in the challenging area of mental health and also has research programs on several under-addressed diseases including tuberculosis, a significant global public health issue. These commitments illustrate how Otsuka is a "big venture" company at heart, applying creativity in everything it does.
Otsuka Pharmaceutical Company is a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan. The Otsuka group of companies employed 50,000 people worldwide and had consolidated sales of approximately USD 11 billion (€ 9.9 billion) in 2016.
All Otsuka stories start by taking the road less travelled. Learn more about Otsuka Pharmaceutical Company on its global website at www.otsuka.co.jp/en. Learn more about Otsuka in the U.S. at www.otsuka-us.com.
Role and Job Description:
The Associate Director, Clinical Analytics IT Business Information Management is accountable for identifying, qualifying, and driving adoption of technology solutions that drive measurable business outcomes for the Clinical Analytics business functions. Acting as the key interface for Clinical Data Management, Programming & Biostatics organization, the role focuses on IT enablement of the various clinical data and analytics portfolio opportunities across multiple business functions. The role will work in close partnership with relevant business/IT stakeholders including internal /external IT delivery/shared services functions to deliver upon the intended business and technology outcomes.
The specific responsibilities of the role include but not limited to:
Business-IT partnership and relationship management
Strategic capability roadmaps, investment planning, and development of business cases /requirements
Technology thought leadership, business consulting and IT advisory services specifically in the areas of emerging technologies, data privacy, and security.
Lead and manage Business Demand, IT portfolio, prioritization, governance, and delivery of the technical capabilities
Business and IT process improvements, innovation and automation opportunity identification and road mapping
Monitors external industry trends and supplier capabilities with a view for continuous improvements
Align diverse stakeholders on objectives and approaches to complex projects; act as a connector between business stakeholders and IT backend /technical operations
Qualifications and Experience:
Minimum of a Bachelor's degree in Computer Science or Engineering is required. MBA or Master's degree preferred with a minimum of 8-10 years of IT experience.
Understanding of all aspects of clinical business domain as well as deeper understanding of clinical data management, programming and biostatistics technologies, platforms, tools and solutions including emerging and legacy technologies and relevance/applicability of that to biopharmaceutical companies
Experience in clinical data mapping, aggregation and reporting technologies such as Oracle LSH, OBIEE, SAS grid, JReview and SDTM conversion tools
Familiarity with EDC/eSource and solutions for external data acquisition including device and wearables technologies
An ideal candidate should have worked in IT consulting, Product management, biopharmaceuticals or adjacent industries such as digital health, CROs, health care etc.
Broader understanding of security and privacy regulations, GDPR, internal/external Audits and CAPA management and anticipate future technology need.
Knowledge of global computer system regulatory requirements as they relate to systems development, testing, and validation preferred including 21 CFR Part 11 requirements.
Insights and knowledge of industry and technology trends and best practices in data integration, application integration, information management, and business analytics including big-data solutions.
Superior presentation skills with the ability to influence, drive action and strategy including ability to effectively interface with senior leadership and demonstrate executive presence.
Up to 20% travel is required, based upon business needs.
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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