Director of Commercial, Market Access and R&D Applications

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 

The Director of Commercial, Quality and R&D Applications is responsible for delivering business-aligned technology services across the Commercial, R&D, and Quality functions of the organization. This role ensures that critical business applications, platforms, and operations are reliable, compliant, and strategically positioned to support growth. The leader acts as a bridge between business stakeholders and IT, embedding technology into core scientific, clinical, and commercial processes. 

Leadership & Governance 

• Build and mentor a cross-functional team that supports Commercial, R&D, and Quality. 
• Manage and build relationships to be able to better predict needs of our partners
• Ensure SMPA applications are aligned and effectively supporting our business goals and operations
• Perform continual optimization of our applications to ensure best in class outcomes and improved efficiency
• Evaluate and bring in where appropriate, new technology/AI enhancements to better enable and reduce
• Educate and train our business partners on AI usage in applications and provide/facilitate application training where needed
• Analyze data, identify trends and work with business to create roadmaps and strategy
• Coordinate with Infrastructure, Operations, and PMO to ensure necessary resources and SDLC processes and documentation are sufficient for the project
• Develop and manage budget for all business applications to ensure adherence to roadmap and organizational objectives
• Drive the selection, implementation, and maintenance of software applications
• Drive change management and communication to strengthen IT/business partnership. 
• Act as a strategic partner to the Head of Commercial, R&D, Technology Operations & Quality ensuring business priorities are translated into measurable IT outcomes. 
• Ensure all systems supporting R&D and Quality meet GxP, GMP, GLP, and GCP requirements. 
• Establish audit-ready processes and validated systems in line with FDA 21 CFR Part 11, EMA Annex 11, and data integrity principles. 
• Drive data integration across R&D and Commercial to improve trial execution, regulatory submissions, and go-to-market readiness. 

  Key Core Competencies

• Strong understanding of Full Product Lifecycle
• 12+ years of progressively increasing experience managing applications in a Pharma/Biotech company
• Strong understanding of building and operating a technology support function

Commercial Applications 

• Own the application landscape supporting Sales, Marketing, Medical Affairs, and Commercial Operations. 
• Enable CRM, data platforms, and analytics solutions that drive market insights, customer engagement, and revenue growth. 
• Partner with business leaders to identify opportunities for AI, digital engagement, and advanced analytics. 

R&D IT 

• Oversee technology platforms supporting Clinical Development, Regulatory, and Pharmacovigilance, including Veeva and related solutions. 
• Ensure systems meet requirements for data integrity, traceability, and audit readiness. 
• Partner with R&D leaders to anticipate needs in clinical trial automation, data integration, and scientific collaboration. 

Quality IT 

• Lead Quality IT systems supporting GxP, GMP, and other regulated environments. 
• Ensure compliance with FDA, EMA, and ICH guidelines for validated systems. 
• Partner with QA/Quality leadership to embed technology into quality management systems (QMS, LIMS, etc.). 

Education and Experience

• BS/BA degree in a related discipline is required. MBA Preferred.

• Advanced understanding of the product lifecycle from compound to commercialization and the supporting