R&D IT Manager

AstraZeneca•Boston, MA

35d

About The Position

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. As Manager, you will be responsible for partnering on business strategy and driving 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 will require the 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 resulting approaches will be based on industry best practices and Alexion standards, while periodically evolving in alignment with future business needs and capabilities. Work will be global and International market-focused as well, 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. You must have excellent communication and customer service skills and must be prepared to regularly use these skills in presentations to colleagues. Constructive communication will be expected down to the most junior staff members as well as up the leadership ladder up to and including the CIO. In all endeavors you must maintain a professional level of preparation and performance. The ideal candidate will have a mixed background of science, technology and informatics and have direct experience managing projects, and delivering a broad range of ‘validated’ solutions in Clinical Development, Regulatory Affairs and Patient Safety.

Requirements

The ideal candidate for this role 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

Nice To Haves

Advanced degree in information technology or information sciences, or specific sciences.
The candidate should have 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

Responsibilities

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.