Daiichi Sankyo, Inc Hiring for Senior Director – R&D Business Systems Owner – Regulatory Information Management job in Remote Full Time

Join a Legacy of Innovation 110 Years and Counting!

Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. Under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.

Summary: The Business Systems Owner is responsible for overseeing the strategic and operational development, deployment and continuous improvement of a portfolio of R&D’s source systems across 1 or multiple R&D Functions, working to ensure high quality data, robust reporting, sound processes, compliance and documentation along with training and support to enable maximum use/value. This role will work in direct partnership with DX/IT Leadership, Technical System Owners and Business SMEs/End Users to drive aligned delivery of R&D systems. Additional key responsibilities listed below:

• Maintain People management responsibilities of business side resource to support system by system delivery including direct and matrix oversight of Business System Leads, Business System Analysts, Business Project Managers, Business Process Engineers, Change Managers and Trainers.
• Build and maintain close relationships and trust across R&D Line Function stakeholders globally, actively listening and seeking out feedback for improvement.
• Define and monitor key metrics of risk and performance of assigned systems as well as satisfaction and uptake in end user consumption.
• Ensure detailed project plans, budget and resource are maintained and communicated between DX/IT and R&D for all assigned systems.
• Bring a cross-system/data vision with the ability to anticipate business needs through a deep understanding of role-based decisions
• Seek to minimize time to launch for new solutions or upgrades, ensuring rigor in documentation and compliance, improving usability and user satisfaction, and ensuring adaptation in system functionalities and supporting processes as the organization changes.
• Build, maintain and oversee effective relationship with external vendors, seeking to ensure optimal spend vs value return within clear timelines and expectation.
• Provide insight into the overall Data, Reporting and Systems strategy, partnering with fellow Business System Owners and other Domain Leads in Global R&D Excellence.
• Present needs/progress of assigned systems directly to the Global R&D IT Council including the development of a future system roadmap & business strategy aligned across R&D systems/owners with input from DX/IT globally.
• Partner with the Head of Data Governance on a plan for master data management as it relates to the flow and use of data across the R&D System Landscape.
• Ensure the necessary agreed business processes are deeply entwined in the fabric of the system and that each system is treated with an agile continuous improvement mindset, with a clear tie to the voice of the customer.
• Govern the ongoing system performance and spend in maintenance phase to drive continues service improvements and cost efficiencies by collaborating with business functions, corporate functions (DX/IT) and vendors.

Responsibilities:

• Establish/Maintain Key Partnerships
• Maintain a seamless and effective partnership with DX/IT throughout the entire System Development Lifecycle of R&D Systems
• Drive collaboration, alignment and awareness across R&D and Non-R&D Functions (DX/IT, CSPV,QA,DX,Legal,Commercial,Med Affairs,Drug Supply) who are either direct or downstream users/consumers of the related R&D Systems
• Align on a common vision/approach/standards for Vendor Selection, Platform Design, Delivery and Continuous Improvement
• Ensure value of R&D technology spend with partners is realized through efficiency and productivity savings as outlined through business cases
• Deliver regular awareness around Progress/Risks/Timelines and Roadmap with the Global R&D IT Council
• Partner with other Global R&D Excellence Domain owners especially Head of MARS, Head of Data Governance and the BELs to work with in a collaborative fashion to understand and delivery on the needs of the business stakeholders
• Manage R&D System Delivery Manage Allocation, Performance and Collaboration of Operational System Leads, Business System Analysts, Business Project Managers, Business Process Engineers and other IT Project Direct roles in the optimal delivery of R&D Systems
• Oversee integrated project plans, timelines, resourcing and risk/issue mgmt. for all projects to ensure on-time, high-quality delivery
• Perform ongoing evaluation and feedback collection of systems to determine necessary maintenance, expansion or decommissioning
• Ensure proper validation, documentation and inspection readiness
• Ensure proper communication, change mgmt. and training to target stakeholders globally
• Ensure Data within Sources systems is maintained to the highest levels of quality and defined standards along with driving towards integrated reporting
• Determine and track KPIs related to system utilization, stability and data quality against defined targets
• Serving as Point of Contact for Audits and Inspections and any resulting CAPAs
• Oversee Access Management and Ticket resolution/Escalation
• Identify, escalate and overcome barriers of delivery, risks & issues
• Manage approved budget and resources to effectively deliver system needs on-time, to budget with high quality

System Strategy, Roadmap and Interdependencies:

• Drive Prioritization, Strategy, Roadmap, Execution and Adoption of R&D Systems working in Partnership with DX/IT and R&D Functions globally
• Establish and actively lead planned, periodic reviews of the overall effectiveness of system, which includes taking any necessary corrective or preventive action to ensure continued success.
• Manage overall System Roadmap across assigned systems including current and planned release schedules and strategic investment direction including input from Corporate functions (DX/IT)
• Drive & Own Budget Use Case Development to ensure necessary funds to deliver future system enhancements
• Outline and map interdependencies across systems/data to ensure consistency and maximization across all Global Line Functions in and outside of R&D

Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
Education Qualifications (from an accredited college or university)

• Bachelor’s Degree Computer Science, LIfe Science, Engineering, Business Administration or a related discipline or equivialent work experience is required. required
• Master’s Degree Life Science or Engineering or Information Systems preferred

Experience Qualifications:

• Minimum twelve years of experience within life sciences supporting the delivery of GXP validated global business systems serving cross-functional stakeholders is required
• Minimum five years managing serving as a single or multiple business systems owner with users in multiple geographical locations and functions required
• Experience within or supporting Research & Development processes, roles and systems is required
• Global experience serving as the liaison between Business & IT, translating business needs into technical solutions and technical jargon into business speak is required
• Experience managing global IT systems either on the IT or Business side is required
• Experience managing a global delivery team is required
• Experience in evaluation, negotiation and oversight globally of both internal and external partners/vendors/resource is required
• Experience implementing a Data Governance strategy is preferred preferred
• Experience managing the deployment of system reporting is preferred
• Knowledge of key industry regulations relating to the compliance of IT Data and Systems is required required
• Proven ability to work in a global and highly matrixed environment is preferred
• Experience supporting an audit/inspection of an IT system is preferred
• Experience ensuring that adequate technology governance controls are included in new vendor contracts with procurement functions globally preferred

Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.