Director, Business Systems & Ops Management ‐ R&D Clinical

Join a Legacy of Innovation 125 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 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, 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

• Required experience as the lead for the operational aspects of one of more areas, such as TMF and other capabilities within Clinical Operations, Clinical Development and Clinical Science.

• Provides leadership and manages TMF function globally (US/EU). Responsible for ensuring complete and accurate TMFs through consistency and application of TMF processes and disciplines.

• This role is the single point of accountability for TMF quality, compliance, and inspection readiness

The Director, R&D Business Systems & Ops Management role 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 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, 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 (G-DIM) 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 will have direct line management of G-DIM 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 the 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.

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 RD 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 RD 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 RD 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 RD 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 G-DIM team members to work in a harmonized fashion across areas of specialization to support project and RD 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

- 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

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 in Computer Science, Life Science, Engineering or a related discipline or equivalent work experience required
- Master's Degree Life Sciences or Information Systems preferred

Experience Qualifications

- Minimum of 10 years of experience within Pharma/Biotech/CRO Drug Development experience supporting the delivery of GXP validated global business systems serving cross-functional stakeholders is preferred.
- Demonstrated experience within or supporting Research & Development processes, roles and systems is required
- Demonstrated experience serving as the liaison between Business & IT, translating business needs into technical solutions and technical considerations into business language is required
- Demonstrated experience managing R&D systems either on the IT or Business side is required
- Excellent oral and written skills are required
- Demonstrated experience involving data governance and/or data stewardship is preferred
- 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
- Experience supporting an audit/inspection of an IT system is preferred
- People Management experience of Business System Analysts, Project Managers and Business Process Engineers to deliver IT Projects is required

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.