Associate Director, IT Research and Development

Sumitomo Pharma Co., Ltd., is a global pharmaceutical company based in Japan with operations in the U.S. (Sumitomo Pharma America, Inc.), focused on addressing patient needs in oncology, urology, women's health, rare diseases, cell & gene therapies and CNS. With several marketed products and a diverse pipeline of early- to late-stage investigational assets, we aim to accelerate discovery, research, and development to bring novel therapies to patients sooner. For more information on SMPA, visit our website https://www.us.sumitomo-pharma.com or follow us on LinkedIn.

Job Overview

We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Associate Director, Clinical Systems R&D IT Business Applications who will serve as the primary liaison between R&D Clinical Operations team and IT, responsible for the delivery and support of technology solutions that align with business needs and operational demands. This role requires proficiency in implementing, integration, and managing Medidata & Veeva clinical systems (e.g. CTMS, EDC etc.) in a regulated environment

 Job Duties and Responsibilities

• Partner with Clinical business stakeholders to co-create technology plans which support their business objectives and operational demands

• Continuously assess current systems environment and identify changes (process and/or system) that enhance effectiveness

• Assist in the evaluation of new technology systems and/or service providers

• Oversee end-to-end management of IT projects—including planning, design, and implementation—ensuring projects are delivered on time, within scope, and with measurable business impact

• Lead a team of managed service providers supporting the lines of business technology needs including project delivery, solution design, enhancement requests and support services

• Accountable for managing clinical application systems through their full lifecycle, from implementation to ongoing optimization

• Lead and initiate troubleshooting quality and/or functionality issues associated with technology systems in scope

• Develop and maintain comprehensive project documentation, ensuring centralized storage and accessibility for knowledge management

• Manage and prioritize system enhancements and fixes in collaboration with business stakeholders

• Provide regular project status reports, manage issues proactively, and adjust schedules as needed while maintaining alignment with the overall program plan

• Manage financial budget allocated to the portfolio (e.g. variance management, forecasting, spend tracking, invoice  approvals and renewals)

• Responsible for timely execution of all GxP system commitments and compliance activities (Backup recovery, Disaster Recovery testing etc.)

• Collaborate with cross-functional IT teams to ensure seamless delivery of services, efficient communication, and shared accountability for outcomes

• Establish clear performance metrics and service level agreements (SLAs) to monitor IT service delivery, project outcomes, and stakeholder satisfaction

• Stay informed of emerging industry trends, best practices, and regulatory changes to proactively recommend technologies and process adaptations that empower the company during phases of rapid expansion

• Serve as the IT subject matter expert for application upgrades, integrations, and system enhancements across supported business areas

  Key Core Competencies

• Strong understanding of Clinical business processes, requirements and technology systems supporting Clinical Trials (e.g. EDC, CTMS, ETMF, Payments etc.)

• 12+ years of progressively increasing experience managing clinical applications in a Pharma/Biotech company