At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society.
Purpose of the function
The role combines global leadership of assigned R&D (RIMS) business systems and operational capabilities for RIMS with leadership of the Europe Delivery Capabilities Center. The role serves as the primary business partner to key R&D functions, drives optimization of business systems, manages operational excellence, and ensures Europe-based resources effectively support global R&D priorities. The role also provides local leadership for workforce management.
Part 1:
The Director, R&D Business Systems & Ops Management is responsible for providing or managing the operational, administrative, and tactical support of 1 or more business systems typically in a single function, along with inputting into the broader systems strategy and landscape. This role is RIMS focused. This role may serve as lead or contributor on projects and initiatives that optimize the use of information technology to achieve R&D and enterprise business objectives. The role will function as a manager of one or more business systems, probably as a leader of sub-teams or workstreams within larger projects or programs, enhancements or changes, as a lead/ contributor within various systems-related working groups, and as an experienced business analyst, as required. This role regularly collaborates with leadership, business process owners, Global Development Information Management (R&D IS) team members, and information technology leads and specialists. The role works under the direction of the lead in the Business Systems & Ops Management area who supports one or more R&D business functions. This role might have direct line management of R&D IS business system owners, business analysts and project managers along with indirect management of business process engineers, trainers, organizational change managers and data analysts supporting systems projects.
This role will also be accountable for the operational aspects of one of more areas, in addition to system ownership. This role may be the single point of accountability and lead for operational data quality, compliance, and inspection readiness at the organization-wide level and decision-making authority for the relevant operational processes. This role may also act as a functional lead and business process owner in representing the related capabilities to other functions within Daiichi Sankyo as well as externally.
Part 2:
The R&D IS European Delivery Center Lead will have responsibility for the local workforce planned to grow to approximately 40 employees by 2030. In providing leadership for the local workforce, this role will be the people manager providing local HR, legal and administrative management support. This lead ensures global demands are being met from a resource management perspective while serving as a global matrix manager navigating key stakeholder agreement.
Line Functions will rely on this position as the Single Point of Contact (SPOC) to ensure fulfillment of operational needs for the existing technology/systems that are supported by R&D IS and on coordination of any new technology need. This role will be responsible for drafting, maintaining and socializing a Line Function Account Plan as a living document guiding the interactions, priorities and global strategy for R&D IS relationship with the respective Line Function in the designated regions/countries.
Key Responsibilities
Systems Administration & Operational Support
- Lead the day-to-day management of the administrative and operational support of assigned systems
- Provides leadership and manages the operational area for the relevant system globally. Responsible for ensuring complete and accurate data ownership/maintenance through harmonization and application of consistent processes and disciplines.
- Monitor, assess, and improve the administrative and operational support processes – including, but not limited, to user access, user experience, user adoption, procedural documents, user training, and issue resolution Identify, evaluate, govern, and prioritize proposed changes to assigned systems anchored to a roadmap, to address the evolving requirements of the user community and to support imperatives identified by Line Function leadership
- Ensure data within assigned systems is maintained to the highest levels of quality and defined standards, and propose improvements to address gaps or sustainability concerns
- Manage user access and monitor/manage ticket resolution/escalation
- Perform periodic voice-of-customer exercises for assigned systems to identify any necessary maintenance, expansion, or user experience improvements
- Define and monitor key metrics of risk and performance for assigned systems
- In collaboration with IT partners, determine the necessary Business/IT resource, budget and Steering Committee required on future IT projects
- Determine and track KPIs related to system utilization, stability, and data quality against defined targets for assigned systems
- Initiate periodic critical reviews of the overall effectiveness of assigned system, which includes taking any necessary corrective or preventive action to ensure continued success
- In collaboration with IT, maintain effective relationships with solution vendors to ensure R&D short and long-term objectives are met within each platform, with an eye towards continuous improvement
Long Description
Project Execution
- Lead all business-led project deliverables including – but, not limited to – process engineering or reengineering, user requirements definition, test scenario & test case development, user training, acceptance testing, and business support & administration
- Ensure that all large and small projects have a formal problem/opportunity statement, business case, return on investment and project charter to clearly articulate the business challenge, benefits, and approach to affect positive information management change
- Oversee the establishment and management of integrated project plans, timelines, resourcing requirements, and risk/issue management evaluations for all projects to ensure on-time, high-quality delivery
- Ensure that the implementation or improvement of all GxP R&D Systems are properly documented to support business utilization and inspection readiness. Support system related inspections as required.
- Identify, investigate, escalate (if necessary), and develop mitigation approaches to identified risks & issues, and/or to overcome any challenges to successful delivery
- Manage and oversee the allocation, performance, and collaboration of internal & external project resources to ensure optimal delivery of R&D systems
- Manage approved budget expenditures and funded resources to effectively deliver system needs on-time, to budget, and with high quality
- Provide regular project status reports identifying progress, risks, mitigation strategies, and timelines for the benefit of stakeholders, leadership, and governance committees
- Lead and/or contribute to working groups or teams formed to address areas of improvement within the R&D scope of operations
- Ensure quality and oversight of delivery partners (DX,DSI IT etc) is in-line with expectations, with clear communication and escalation where needed
- Lead or contribute to ad hoc projects or initiatives, as assigned
Business Analysis
- Function as an experienced Business Systems Analyst within large projects or other appropriate situations, as assigned by the Global Business Systems Owner
- Directly develop formal problem/opportunity statements, business cases, and project charters to clearly articulate the business challenge, benefits, and approach to affect positive information management change, as required
- Provide business-focused project deliverables including – but, not limited to – process engineering or reengineering, user requirements definition, test scenario & test case development, user training, acceptance testing, and business support & administration
Project Execution
- Lead all business-led project deliverables including – but, not limited to – process engineering or reengineering, user requirements definition, test scenario & test case development, user training, acceptance testing, and business support & administration
- Ensure that all large and small projects have a formal problem/opportunity statement, business case, return on investment and project charter to clearly articulate the business challenge, benefits, and approach to affect positive information management change
- Oversee the establishment and management of integrated project plans, timelines, resourcing requirements, and risk/issue management evaluations for all projects to ensure on-time, high-quality delivery
- Ensure that the implementation or improvement of all GxP R&D Systems are properly documented to support business utilization and inspection readiness. Support system related inspections as required.
- Identify, investigate, escalate (if necessary), and develop mitigation approaches to identified risks & issues, and/or to overcome any challenges to successful delivery
- Manage and oversee the allocation, performance, and collaboration of internal & external project resources to ensure optimal delivery of R&D systems
- Manage approved budget expenditures and funded resources to effectively deliver system needs on-time, to budget, and with high quality
- Provide regular project status reports identifying progress, risks, mitigation strategies, and timelines for the benefit of stakeholders, leadership, and governance committees
- Lead and/or contribute to working groups or teams formed to address areas of improvement within the R&D scope of operations
- Ensure quality and oversight of delivery partners (DX,DSI IT etc) is in-line with expectations, with clear communication and escalation where needed
- Lead or contribute to ad hoc projects or initiatives, as assigned
Education & Experience
- Bachelor's Degree Computer Science, Life Science, Engineering, Business Administration or a related discipline or equivalent work experience required; Master's Degree Life Sciences or Information Systems preferred
- Minimum of 10+ years of experience within life sciences supporting the delivery of GXP validated global business systems serving cross-functional stakeholders
- Demonstrated experience within or supporting Research & Development processes, roles and system
- Demonstrated experience serving as the liaison between Business & IT, translating business needs into technical solutions and technical considerations into business language
- Demonstrated experience managing R&D systems either on the IT or Business side is required
- Demonstrated experience involving data quality and/or data stewardship is preferred
- Experience supporting an audit/inspection of an IT system preferred
- 10+ years of experience for Line Management experience of Business System Analysts, Project Managers and Business Process Engineers to deliver IT Projects as well as line management experience of a relevant/comparable business operation
- Excellent oral and written communication skills are required
- Knowledge of key industry regulations relating to the compliance of IT Data and Systems is required
- Proven ability to work in a global and highly matrixed environment is preferred
