• Manage and prioritize a portfolio of related initiatives via a business partner team
• Drive annual IT related business initiative road mapping
• Partner with business process owners and technology partners to elicit, analyze, translate, and document business processes and requirements into actionable user and functional requirements.
• Assist business units with solution and vendor assessment
• Develop budgets, plans, and project manage implementations of appropriate solutions to ensure that projects are delivered on time and within budget and meet business need.
• Support overall department related IT financials budget and actuals
• Manage Request for Proposal Process(RFP) including documenting requirements, identifying and engaging vendors, product selection processes, oversee contracting and negotiations, and manage product vendors
• Work with external parties (e.g. CROs, AMC’s, Vendors) to analyze, define and document data and information flows impacting preclinical, development & operations
• Work in concert with the user community to actively manage change and optimize solutions through their lifecycle
• Support systems validation/testing to regulatory compliance standards
• Support cloud-based IT infrastructure for big data analytics and storage
• Enhance solutions to insure optimum utilization of resources and regulatory compliance
• Provide guidance and advisory services in the areas of industry best practices as well as systems and solutions to improve effectiveness and efficiency.
• Thorough understanding of and demonstrable experience in the oncology-based Research & Development space
• Ability to work well and collaborate with a wide range of team members including technical, business subject matter experts and stakeholders
• Ability to adapt quickly to new business processes, technologies and changing business requirements
• Solid project and time management skills including the ability to create compelling business cases with accurate cost and effort estimations; requirements elicitation; project facilitation; use case and activity diagram development
• Previous experience with R&D systems including but not limited to electronic lab notebooks (ELN), biomarkers, and genomic information.
• Experience and knowledge of supporting cloud based high power computing with big data
• Experience in managing external vendors through selection, contract negotiation, implementation and ongoing maintenance/support.
• Excellent understanding of business complexity and project interdependencies
• Solid knowledge of MS Project Server application, use and support models.
• Sufficient understanding of other business areas (e.g., commercial, clinical, G&A) to identify R&D projects with the potential to impact multiple business areas.
• Knowledge of and experience with cGXP Software Validation, applicable FDA regulations and ICH guidelines, and a risk-based approach to solution implementation.
Abilities Needed for Success:
• Excellent oral and written communication skills for effectively interfacing with all levels of management and departments within the company.
• Ability to make thoughtful, integrated, timely and meaningful decisions and take corresponding actions.
• Proven ability to work with a high level of integrity, accuracy, and attention to detail
• Self-motivated, and confident
• Has the desire to act with urgency and passion.
• Strong organizational skills in order to maintain a high level of productivity, innovation, and priority-setting in order to complete assignments on-time and on-budget.
• Willingness to work collaboratively by incorporating diverse perspectives and appropriately managing relationships in order to strengthen decision-making.
• Proactively seeks out and recommends process improvements.
• Entrepreneurial, enjoys working in a fast-paced, small-company environment.
• Flexibility in handling work flow in a multi-tasking environment.
• Passion for learning and adapting fast moving technology
• Ability to work under pressure, meeting time sensitive deadlines, while maintaining a high level of confidentiality.
• 10+ years industry experience
• Bachelor’s degree in computer science. management information systems or related field
• A consulting, Biotech, Bio pharma, Life sciences background is a plus
• Previous experience in rapidly growing organizations is preferred
• Previous experience with oncology-based big data and cloud computing are desired
• Experience in life sciences a plus including IT and business operations solutions for Nonclinical and Translational R&D functions, Project and portfolio management and reporting, etc.