Manager, R&D Applications

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November 15

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Sumitomo Pharma America, Inc.

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Biotechnology • Pharmaceuticals • Healthcare Insurance

Sumitomo Pharma America, Inc. is dedicated to improving the health and well-being of people around the world by driving innovative treatments, science, and technology. The company focuses on addressing patient needs in critical areas such as psychiatry & neurology, oncology, urology, women's health, rare diseases, and cell & gene therapy. As a subsidiary of Sumitomo Pharma Co. , Ltd. , SMPA embodies the promise of combining technology and life-sciences expertise to improve patient outcomes. With a diverse pipeline of preclinical and clinical programs, SMPA is committed to delivering patient-first solutions through a technology-driven approach.

1001 - 5000 employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

📋 Description

• 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 • 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

🎯 Requirements

• 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 • 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 Systems Validation process

🏖️ Benefits

• Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases • short incentive plan participation • eligibility for our 401(k) plan • medical, dental, vision, life and disability insurances • robust time-off policy which includes flexible paid time off • 11 paid holidays • additional time off for a shut-down period during the last week of December • 80 hours of paid sick time upon hire and each year thereafter