Manager - 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.   

Job Summary:

• Required experience in business analysis and process designs in TMF and other systems/area in the R&D clinical space.

• Experience in Veeva clinical platform, especially in clinical trial management.

• Experience in working in an outsourced environment (from a sponsor or a CRO side).

The Manager, Business Systems & Ops is responsible for optimizing business processes involved in pharmaceutical R&D using technology solutions/services and providing the analytical support to make them efficient, effective and/or improve the overall quality. This role also proactively collaborates with the global development functional groups and other internal GDIM (Global Dev Information Management) team members globally to gain more understanding of any specific nuances that Daiichi Sankyo may have in their business processes and use that to produce proposals to drive efficiency, compliance, and innovation.

A primary focus of this role is on processes or sub-processes in different domains where there are gaps and there is a need to address them through a people/process/technology/ or data framework. Depending on the magnitude of the specific projects, this role will require the ability to operate independently or collaborate with one or more Business Analysts (BA) and/or Business Process Experts (BPE) assigned to their specific project.

This role regularly collaborates with leadership, business process owners, GDIM team members, and information technology leads and specialists to understand the capabilities required to optimize business processes, to assess the current state, define a desired future state, and to develop or contribute to the business and technology artifacts associated with the implementation, change, and operation of business systems. Their primary objective is to improve operational efficiency, streamline processes, and drive innovation within the R&D function. This role will be responsible for influencing key stakeholders by collaborating with other functional SMEs.

Responsibilities:

Business Analysis:

• Lead or collaborate on discovery concept phase activities including (but not limited to) current state assessments, key stakeholder interviews, surveys, policy procedural reviews, document analysis, requirements workshops, and use cases.

• Lead or collaborate on analytical and critical evaluation activities including (but not limited to) to-be process engineering, definition of process roles and responsibilities, identification of test scenarios test cases, creation of training plans training materials, authoring of procedural documents, and work aids for efforts involving the implementation of, or changes to, information technology business systems.

• Proactively communicate and collaborate with external and internal customers to analyze information needs and functional requirements.

• Critically evaluate information gathered from multiple sources, reconcile conflicts, decompose high-level information into details, abstract up from low-level information to a general understanding, and distinguish user requests from the underlying business needs.

Business Process Reengineering:

• Analyze existing RD processes, identifying bottlenecks, and developing strategies to improve efficiency, reduce costs, and enhance productivity.

• Ensure that RD processes align with regulatory requirements and industry standards, such as Good Clinical Practice (GCP) and Good Laboratory Practice (GLP).

• Responsible for proactive and effective business process mapping methodology for the development of To-be and As-Is maps and requirements. Define “As-Is” optimized “To-Be” business processes to develop requirements and business model changes – provide into the overall harmonized software process design (Business Process Guide).

• Manage (develop / update / review and approval, etc.) business SOPs as needed and as impacted by project.

Project Definition, Planning, and Management:

• Develop or collaborate in the development of a Problem Statements, Business Cases, High-level Project Plans, Project Charters, and Project Proposals to frame each business system opportunity or problem, identify the benefits to be realized, and define the anticipated effort and timeline for each proposed project or significant system change.

• Assist project leads and project managers in planning projects, establishing work plans, determining the anticipated effort, estimating resource requirements, and identifying required deliverables.

• Assist project leads and project managers in tracking, communicating, and reporting on project status, as well as developing materials for presenting various aspects of proposed or in-progress projects.

Relationships Collaboration:

• Collaborate with other GDIM team members globally and external RD function SMEs 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.

Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

Education:

• Bachelor's Degree Computer Science, Life Science, Engineering, Business Administration or a related discipline or equivalent work experience required Experience Qualifications

Experience:

• Minimum of 5 years of experience within life sciences supporting the delivery of GXP validated global business systems serving cross-functional stakeholders is required required

• Demonstrated experience within or supporting Research & Development processes, roles and systems is required required

• Demonstrated experience in translating business needs into technical solutions and technical considerations into business language is required required

• Demonstrated experience working with one or more R&D systems either on the IT or Business side is required required

• 4 or More Years Excellent oral and written skills are required required

• Proven ability to work in a global and highly matrixed environment is preferred 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.