• Senior Manager R&D Digital and eSolution Delivery

    Job Locations US-MD-Rockville
    Requisition ID
    2018-10495
  • Responsibilities

    Reporting into Director, Business Information Management, the Senior Manager/Associate Director - R&D eSolutions Delivery is responsible for delivery implementation, execution, integration and transformation of clinical trial technologies and digital technologies. This role will closely partner and collaborate with various global R&D business functions, the internal and external IT services organizations, various suppliers, and other key stakeholders to identify and enable enterprise grade cost effective digital, mobile, and eSolutions leading to the accomplishments of the following key goals/objectives in addition to applicable operational, strategic, and fiscal responsibilities:

    • Improved user experience and predictable delivery of business outcomes through technology enablement
    • Improved cycle time for R&D deliverables through digitalization and automation
    • Technology driven and enabled productivity/efficiencies
    • Managing budget, schedule, timeline and release management activities on an ongoing basis
    • Enabling near real time accessibility of R&D data to drive greater insights and rapid decision making

    Key Job Responsibilities

    • Develop and execute a continuous improvement framework within OIT R&D team to drive innovative process and system improvements that enable compliant and efficient R&D processes and clinical trial delivery.
    • Participate and contribute to R&D Innovation Forums to identify opportunities for enabling technical capabilities that will improve trial operations and outcomes.
    • Lead, develop, coordinate and implement strategic technical projects – prototypes and pilots, across OIT and R&D functions aligning with business objectives.
    • Develop applicable business cases and key performance indicators (KPIs) to demonstrate overall return on investment.
    • Coordinate across various delivery teams, architects, support teams and business stakeholders to understand and drive all aspects of solution delivery including but not limited to managing schedule, priorities, governance plan, agenda setting, UAT coordination, demand management, change management, communication and establish delivery cadences.
    • Management, metrics tracking and successful delivery of innovation and continuous improvement and transformative IT solutions.
    • Identify, collect and analyze relevant metrics to develop a comprehensive understanding of R&D processes, clinical trial execution, technology operations and overall platform performance including but not limited to quality, cycle time, cost, integration, and the voice of the customer (e.g., business functions, patients, consumers, affiliates, partners and vendors).
    • Collaborate on the development of a communication tool to provide at-a-glance views of metrics summaries, key trends, comparisons and exceptions. Develop reports using this data and highlight movements in key process metrics over the continuous improvement lifecycle. Make continuous improvement recommendations based on this data.
    • Maintain a solid knowledge of the end to end Clinical Development pathway. Understand upcoming technical strategy and directions that regulatory agencies will be expecting movement towards in the future.
    • Collaborate with experts to understand the potential impact on Otsuka’s end to end processes – technically, operationally, & fiscally. Communicate these findings and recommendations to OIT Leadership Team.
    • Participate and contribute to technical vendors and digital/eSolution assessments for best fits based on technical and business strategy and portfolio across R&D clinical eco-systems

    Technical Leadership/Management

    • Act as a change agent to create an operational and technical excellence culture and deliver measurable outcomes.
    • Establish and maintain strong working relationships with both internal and external collaborators and stakeholders across all Otsuka geographical regions. Includes close working relationship with the R&Doperational and clinical development teams and their direct reports
    • Establish agile and dev-ops delivery framework to meet competition business demand.

    Qualifications

    Knowledge/Experience

    • Minimum of a bachelor’s degree (BS/BA) in a scientific/engineering/technical/pharmaceutical discipline, preferably combined with relevant clinical trial and technical eTrial/eSolutions or related digital and social technologies experience. Preferably a graduate degree in technology or business.
    • A minimum of 10 years working within a Pharmaceutical environment or related discipline e.g. Quality, project delivery in a fast pace environment with proven global and cross-functional management, technology and process harmonization experience.
    • Strong understanding of drug development process, global regulatory environment and eSolution implementation (ex., eConsent, RBM, eSource, eSurveillance, eTMF, related mobility, social and digital technologies).
    • Results oriented, comprehensive knowledge of data integration, enterprise solutions, R&D innovation, and internal/external customer focus
    • 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


    Skills

    • Superior presentation skills with the ability to influence, drive action and strategy.
    • Strategic and technical skills sufficient to enable confidence and leadership.
    • A strong understanding of the clinical research and drug development lifecycle
    • Deeper understanding of modern digital trend and technologies
    • Leadership and relationship management skills are essential
    • Excellent communication and interpersonal skills.

    Travel (approximately 25% global)

    Overview

    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 a youthful spirit of 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 45,000 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.

    Disclaimer

    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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