Associate Director, R&D IT

Overview:

This position reports to the Executive Director, IT - Commercial and R&D and is a “hands on” role responsible for overall management and delivery of business applications for the R&D organization.  This role is a key enabler of business capabilities for Clinical Operations, Clinical Logistics, Clinical Sciences, Regulatory Affairs, Drug Safety, Biometrics, and Research.  The ideal candidate will possess excellent communication/facilitation skills and strong experience developing systems in the Pharma/Biotech industry. This position works directly with the business functions to develop plans, implement systems and institute operational controls to ensure that the application portfolio meets the needs of the business.  This role will also monitor the performance of IT services and partner with vendors for managed services.

Primary Responsibilities:

• Establish and build productive relationships with internal stakeholders, internal technology teams, and external technology vendors.
• Serve as subject matter expert in identification, evaluation, design, development, and deployment of systems, processes, data and reporting to build R&D capabilities.
• Broker discussions with business stakeholders to develop project charters/plans that are used to prioritize the portfolio and make tradeoffs, ultimately resulting in implementation road maps.
• Manage multiple vendors including completion of RFPs/RFIs, vendor due diligence, negotiating the business terms of IT contracts, oversight of vendor fulfillment of contractual responsibilities, evaluation of policy and procedure adherence, and monitoring service level agreement performance.
• Drive and execute operational controls including change control, release management, user access, and business continuity.
• Responsible for the entire lifecycle of the application(s) (i.e., requirements, design, testing, validation, deployment, operational support, and incremental enhancements).

Qualifications:

• Strong experience with biotech/pharma R&D processes and systems (e.g. regulatory authoring & submissions, CTMS, safety systems, statistical programming environments/tools, samples tracking, analytics, etc.)
• At least 8 years of increasing leadership experience working in biotech/pharma and information technology.  Experience with cell and gene therapies is a plus.
• Experience managing IT delivery vendors to ensure excellence in execution, product quality, and operational effectiveness.
• Must be a willing hands-on contributor when needed and exhibit resilience in working across multiple functions (in some cases, outside of R&D).
• Strong background in Computer Systems Validation with familiarity of all the necessary artifacts.
• Strong interpersonal, facilitation, presentation, and communication skills.
• Ability to communicate complex problems in a non-technical and simplified manner to stakeholders and end-users and to effectively communicate business needs to technology teams.
• Possesses sense of urgency; identifies challenges and problems and takes the initiative to identify solutions.
• Project management skills and focus on delivery of results.
• Foundational understanding of SDLC and ITIL and change control concepts.

Preferred/Desirable Knowledge, Skills, and Education:

• Veeva Vault certification or other relevant certifications.  Familiarity with Vault RIM, eTMF, or CTMS are advantageous.
• Salesforce experience is beneficial.
• Experience with Cloud architecture and integration strategies/concepts.
• Understanding of Data Visualization/Dashboards/Reporting, including experience with Tableau or Spotfire.
• Bachelor's or Master's in Computer Science or relevant degree

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