Lucas Group has partnered with a growing pharmaceutical company seeking a Director IT Scientific Affairs with strong Biomedical/Pharmaceutical background on a direct-hire basis.
This is a mission critical role that impacts both internal and external customers.
Key Functions:
• Develop IT systems strategy and road maps for Scientific Affairs in line with global IT standards. Collaborate with Medical Affairs Solution Leader in developing a robust road map for R&D.
• Work with business leaders and partners in developing process based on best practices for Regulatory Affairs, portfolio management, etc. in line with business needs and requirements.
• Work with enterprise application team and infrastructure to identify IT solutions as well as the required system architecture to satisfy business needs.
• Measure and deliver project / program outcomes successfully. Implement and/or adapt processes and metrics to ensure project goals and objectives are achieved. Set performance objectives and incorporates feedback from team and organization for continuous improvement.
• Review business cases to understand scope, timeframe, funding limitations, risks and staffing requirements for the project phases; coordinate and respond to requests for changes from original scope.
• Leverage project outcomes globally, assisting other business units, regions and countries where needed on global projects. Coordinate project activities with activities of other projects.
• Lead and influence resources through a matrixed environment in which some required resources do not have a direct reporting relationship. Manage and mentor a team of business analysts as well as project managers.
Key Requirements:
• Minimum of a Bachelor's degree (or equivalent) and 8+ years of experience required.
• Must have experience running large globally scoped IT programs with strong understanding of project management principles
• Experience in the pharma industry preferred, experience in regulated/validated process industry is a must
• Knowledge of FDA, EU and other regulatory issues specifically in the GxP arena is strongly preferred.
• Previous supervisory experience required as this role will manage direct employees and contractors.
• Work effectively in a highly matrixed environment.