Director, Informatics Solutions

4 weeks ago


Basking Ridge, New Jersey, United States BioSpace, Inc. Full time
Job 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.

Key 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.
  • Work with User Support Leads and the business users to define user information needs.
  • Provide informatics project management, SDLC Quality Model expertise, and computer system validation expertise to deliver applications solutions to meet business needs.
  • Assemble 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 information system roadmaps.
  • Provide such reports that are required to update both management and the business on the progress and status of informatics projects.
  • Contribute to the R&D IT portfolio management process and participate in IT and R&D governance forums.
  • Provide identification and evaluation of new information systems and technologies as they relate to the DS business; provide R&D IT Application solutions/innovations.
Qualifications
  • Bachelor's Degree in Computer Science, Life science, Engineering, Business Administration and / or a related discipline required.
  • Master's Degree in Life Science or Engineering or Information systems preferred.
  • 10 or More Years experience in applications development and operation in the pharmaceutical industry within the appropriate regulatory guidelines required.
  • Experience in working within the framework of 21 CFR Part 11, SDLC, GAMP, ICH preferred.
  • PMP Certification preferred.


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