Associate Director, Informatics
Daiichi Sankyo
2024-11-05 10:36:34
Basking Ridge, New Jersey, United States
Job type: fulltime
Job industry: Executive Positions
Job description
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.
Job Summary
Deliver the development and implementation of informatics systems and programs to support the business functions of Daiichi Sankyo (DS) in the US, EU, Japan, and other global sites. These business functions include: Clinical Operations, Clinical Development, Biostatistics and Data Management, Regulatory Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/Risk Management, Quality Assurance, Medical Affairs, Translational Research, Research, Informatics Services, Project Management and Operational Management. Develop a strong, positive strategic business partnership with the global R&D business and Global IT functions of Daiichi Sankyo. As a trusted partner, provide oversight of technical and solutions architecture and design for the R&D IT portfolio and to ensure that partners receive the highest possible business value, while subscribing to the enterprise IT strategy.
The AD Informatics is a Solutions Architect who supports the planning & definition, acquisition, design & system build, and testing phases of systems development of global informatics Systems and programs, ETL and integrations. Leads enterprise level technical projects to ensure homogeneity within IT. Collaborates with technical and business leaders to ensure business continuity and unified direction. Serves as a knowledge source for Informatics on systems development. Provides technical leadership for project teams
Responsibilities
Provide the interface between the business and the technology providers to deliver R&D information applications solutions. Establish strategic vendor management relationship and governance. Responsible for Strategic Application product roadmaps to meet business objectives.
Lead the definition of solutions based on business needs, cost, and required integration with existing applications / systems / platforms. Work with project teams to analyze solution needs and produce preliminary solution design and architectural diagrams. Lead technical feasibility discussions, prototype development, and design efficient, adaptable, and scalable architectures in accordance with company policies, regulatory standards, and integration methodology.
Work with the business users to define user information needs, research innovative product value proposition and collect ideas for future roadmaps and planned projects;
develop business cases to secure the necessary funding and resources for their successful implementation.
Accountable for managing Technology roadmaps of relevant systems and architecture. Advocates for good architecture and design practices and compliance in all relevant areas. Assists IT and business leadership in understanding large technical projects and solutions.
Oversees solution delivery, ensuring adherence to original design and development best practices and the Daiichi Sankyo Integration Methodology. Provide informatics solution architecture expertise to all systems implementation projects. Performs regular solution/code reviews with technical teams to ensure compliance with standards. Leads in process improvement and develops procedures to improve overall IT systems development with a focus on maintainability of solutions and reuse.
Maintains detailed Solution Architecture diagrams for ALL systems, integrations, and data flows. Work with the Enterprise Architecture team to ensure all enterprise architecture documentation accurately reflects the solution architecture and is kept up to date. Provide such reports that are required to update both management and the business on the progress and status of informatics projects. Contribute to the annual IT investment ideation and planning process, manage project budget requirements and participate in IT and R&D governance forums.
Education
Bachelors Degree in Computer Science, Life Science, Engineering, Business Administration and / or a related discipline is required.
Masters Degree in Life Science or Engineering or Information Systems is preferred.
Experience
At least 7 years experience in applications development and operation in the pharmaceutical industry within the appropriate regulatory guidelines.
7+ years' experience in system integration development.
Previous experience in architecting Solutions and providing technical oversight within Pharmaceutical R&D areas
3+ years' experience developing system integrations using Informatica.
Experience in the pharmaceutical industry working within the framework of 21 CFR Part 11, SDLC, GAMP, ICH