Director (m/f/d), R&D Business Systems & Ops Management

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

• 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

• Relationships & Collaboration

• Collaborate with other Global R&D IS team members to work in a harmonized fashion across areas of specialization to support project and R&D objectives

• Build and maintain close relationships with subject matter experts, information technology colleagues, business leads, vendors and external resources in executing projects or other initiatives

• Contribute to System Roadmaps across assigned systems including current and planned release schedules and strategic investment direction

• People Management & Leadership

• Lead a rapidly growing team of new employees across several roles to ensure quality and timely delivery

• Support the development of the local R&D IS employees

• Track and report the location’s performance across measures/KPIs. Proactively identify risks and issues and collaborate with global functional lead(s) to drive resolution

• Development talent and support development and implementation of career ladders

• Building out the local team further

• Coordinating with R&D IS DSJ delivery center (once up and running in Phase 2/3)

• Essential Function

• Accountable for the management, development, recruitment and training of employees within the departmental scope to meet current and future business needs.

• Provides leadership by attracting and retaining top talent, developing team members, and ensuring organizational effectiveness, transparency, and communication.

• Manages and provides guidance to team members, including organizing and prioritizing group tasks, performing training, and managing performance.

• Responsible to create an environment where employees feel engaged and empowered, to be successful in their responsibilities, and deliverables.

• 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

• Why work with us?

• Working at Daiichi Sankyo is more than just a job – it is your chance to make a difference and change patients’ lives for th