Director, Informatics in Basking Ridge, NJ at DSI

Date Posted: 10/2/2020

Job Snapshot

Job Description

Join a Legacy of Innovation 110 Years & Counting!

With over 100 years of scientific expertise & a presence in more than 20 countries, Daiichi Sankyo & its 15,000 employees around the world draw upon a rich legacy of innovation & a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for hypertension & thrombotic disorders, under the Group’s 2025 Vision to become a “Global Pharma Innovator with a Competitive Advantage in Oncology,” Daiichi Sankyo research & development is primarily focused on bringing forth novel therapies in oncology, including immuno-oncology, with additional focus on new horizon areas, such as pain management, neurodegenerative diseases, heart & kidney diseases, & other rare diseases.

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. Develop a strong, positive strategic business partnership with the global R&D business 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 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. Collect ideas for upcoming projects and help develop business cases to secure the necessary funding and resources for their successful implementation.

Provide informatics project management, SDLC Quality Model expertise, and computer system validation expertise to deliver applications 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 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: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.

Education/Experience:

Bachelor’s Degree in computer science, Life science, Engineering, Business Administration and/or a related discipline is required.

Master’s degree in Life Science or Engineering or Information systems is preferred.

At least 10 years’ experience in 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.
PMP Certification preferred.

Ability to travel to US, EU and Japan up to 10%.

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.