Associate Data Director - New Jersey, United States - Daiichi Sankyo, Inc.

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.

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.

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.

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. Serves as a knowledge source for Informatics on systems development. Provides technical leadership for project teams
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. Assists IT and business leadership in understanding large technical projects and solutions.
Provide informatics solution architecture expertise to all systems implementation projects.

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.

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.

Bachelors Degree in Computer Science, Life Science, Engineering, Business Administration and / or a related discipline is required.

At least 7 years experience in applications development and operation in the pharmaceutical industry within the appropriate regulatory guidelines.

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
Travel
Ability to travel up to 10% DSE, DSJ locations which will include overnight travel. Ability to travel to US, EU and Japan

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.