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
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.
Experience in implementing, integrating, and managing Medidata & Veeva clinical systems (e.g. CTMS, EDC etc.) in a regulated environment is a requirement.
Mastery of Medidata products and suites, including Rave EDC, CTMS, Monitoring Templates, Site Payments, Core Configuration, Visual Analytics, User/Site Administration and other configuration modules.
Proven ability to lead Site Monitoring Configuration efforts, managing visit templates to streamline CRA workflows and improve monitoring efficiency
Advanced understanding of Clinical Trial requirements and technology systems.
12+ 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
Excellent communication skills
The base salary range for this role is $155,440 to $194,300. 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 and leaves provided in line with your work state. Our robust time-off policy includes flexible paid time off, 11 paid holidays plus 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. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law.
Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.
Confidential Data: All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential.
Compliance: Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Mental/Physical Requirements: Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.
Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) employer
Qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.