R&D IT Manager

This Is What You Will Do

As Manager R&D IT, you will be a member of the R&D IT team reporting directly to the Sr. Director of R&D IT that has accountability to Alexion’s Heads of Research and Development functions. You will partner on business strategy and drive process, technology and use of R&D data across Clinical, Biostatistics, Regulatory and Drug Safety functional areas. Particular focus will be on fostering the pervasive use of AI across Alexion R&D, and identifying and delivering high‑value AI‑driven solutions.

The role requires an ability to execute IT and business strategy to R&D priorities with a "hands‑on" approach in delivering IT and data solutions. You will work with IT and business partners to create a best‑in‑class architecture framework to support the fast‑changing needs in the company. The approaches will be based on industry best practices and Alexion standards, while periodically evolving in alignment with future business needs and capabilities.

Work is global and internationally market‑focused, ensuring the disparate needs of the Rare Disease Unit are delivered for value. You will focus significant attention to investigation, experimentation, and delivery of innovative solutions.

• Serve as key point of contact and IT business partner with one or more of the following business areas:
  Clinical Development, Regulatory Affairs and Patient Safety
• Create a business partnership and ensure close cooperation between all functions and IT
• Develop and execute on plans for roadmaps for the information, data, and process needs of the business areas listed
• Author GxP documentation such as requirements specifications, data models, test plans, and other SDLC deliverables
• Partner with IT and Development leaders to clarify requirements and prepare appropriate project deliverables and requirements
• Drive the execution of IT projects in collaboration with suppliers, business partners, team and management
• Understand and communicate the implications of technical decisions on the business, application, and project timelines and influence decisions accordingly
• Define, lead, and execute technical work, software integration, and data integration activities
• Create and adapt to new ways of working, with an emphasis on helping to drive innovative solutions
• Define, plan, and oversee budget for projects as required

• The ideal candidate has a minimum of 3 years working either in or near a biopharmaceutical Development Sciences role either within IT and/or in Development function itself
• Undergraduate degree in computer science, information technology, business or related field
• Strong R&D business background with experience and partnering with at least one of the teams in Clinical, Regulatory, Safety, Pharmacovigilance and Biostatistics areas
• Proven track record of innovation utilizing technology, partners and teams tied to business outcomes
• Detail‑oriented, self‑starter and able to work both independently and in a team environment
• Experience managing technical resources and project teams
• Experience with Development systems and processes (e.g. eTMF, CTMS, eCRF, eSubmission, eCTD, SAS, Documentum, Veeva for R&D, etc.)
• Strong analytical and critical thinking skills
• Strong architectural and application development background
• Strong understanding of data models and architecture
• Ability to manage multiple projects under tight timelines
• Understanding of PMI methodologies and project management experience
• Excellent verbal communication skills
• Experience with formalized change management processes
• Experience of both regulatory (GxP) and corporate compliance domains

• Advanced degree in information technology or information sciences, or specific sciences
• Prior experience integrating systems in at least one of the following to support regulatory submissions including data management, statistical programming, serious adverse events, document management, and/or clinical trial metrics
• Proven track‑record of delivering scientific projects utilizing agile SDLC
• Mastery of both regulatory (GxP) and corporate compliance domains

The annual base pay (or…