Associate Director, Informatics

Location
Basking Ridge, New Jersey
Posted
Jul 23, 2021
Ref
10656BR
Hotbed
Pharm Country
Required Education
Bachelors Degree
Position Type
Full time
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. Summary Deliver the development and implementation of Research & Development (R&D) 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 business demand to balance R&D IT portfolio and to ensure that partners receive the highest possible business value, while subscribing to the enterprise IT strategy. Responsibilities
  • Provide informatics solution architecture expertise, project management, SDLC Quality Model expertise, and computer system validation expertise to deliver applications and solutions to meet business needs. Assemble and manage applications solutions implementation teams (including external vendors) in the design, development, implementation, validation, roll-out, training and support of global and regional DS systems to meet business needs using a standard methodology. Oversee applications support groups’ system validation and change control process. Develop and manage information system roadmaps.
  • 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.
  • 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.
  • 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 budgets and participate in IT and R&D governance forums.
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 Computer Science, Life Science, Engineering, Business Administration and / or a related discipline required
Master's Degree Life Science or Engineering or Information Systems preferred Experience Qualifications
  • 7 or More Years applications development and operation in the pharmaceutical industry within the appropriate regulatory guidelines.
    Experience in working within the framework of 21 CFR Part 11, SDLC, GAMP, ICH required
Licenses and Certifications
  • Certified Project Management Professional (PMP)-PMI preferred
TravelAbility to travel up to 10% DSE, DSJ locations which will include overnight travel. Ability to travel to US, EU and Japan 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.