Manager, R&D

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  or follow us on Linked In.

Job Overview

We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Manager, 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
• Work with 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
• 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.)
• 7+ years of progressively increasing experience managing clinical applications in a Pharma/Biotech company
• Strong understanding of building and operating a technology support function
• Proficient in implementing, integration and managing Medidata & Veeva clinical systems (e.g. CTMS, EDC etc.) in a regulated environment

Education and Experience

• BS/BA degree in a related discipline is required. Training or equivalent experience in IT or business management is beneficial but not required
• 7+ years of experience in life sciences with a focus on IT system delivery
• 5+ years of experience in implementing, integration and managing Medidata & Veeva clinical systems (e.g. CTMS, EDC etc.) in a regulated environment
• Experience in Program & Project Management, including the Software Development Lifecycle and Computer…