Reporting to the Director, Business Partner, Research and Clinical Development, the Associate Director, Research & Development IT Business Partner will be responsible for working with R&D business units including discovery, preclinical development, and translational sciences. Key tasks will be to help these units define short and long-term plans including related priorities and budgets, development of business processes and as well as support selection, implementation and administration of related business solutions.
- Manage and prioritize a portfolio of related initiatives in the discovery, preclinical development, and translational sciences business partner teams
- Partner closely with scientific, regulatory, and operational end users to elicit, analyze, translate, and document business processes and requirements and identify appropriate software solutions (e.g, GxP and non-GxP)
- Support cloud-based IT infrastructure for big data analytics and storage
- 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 scientific and operations stakeholders
- 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
- Support systems validation/testing to pre-clinical regulatory compliance standards
- Enhance solutions to insure optimum utilization of resources and regulatory compliance
- Drive annual IT related business initiative road mapping
- Thorough understanding of and demonstrable experience in the Pharmaceutical Research & Development space
- Experience and knowledge of supporting cloud based high power computing with big data
- Ability to work well and collaborate with a wide range of team members including technical, business subject matter experts, and stakeholders
- 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 pharmaceutical R&D systems including but not limited to electronic lab notebooks (ELN), biomarkers, and genomic information.
- Experience in managing external vendors through selection, contract negotiation, implementation, and ongoing maintenance/support.
- 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.
- Familiarity with cGXP Software Validation, applicable FDA regulations and ICH guidelines, and a risk-based approach to solution implementation is a plus.
Abilities Needed for Success
- Excellent oral and written communication skills for effectively interfacing with all levels of management and departments within the company.
- Proven ability to work with a high level of integrity, accuracy, and attention to detail
- Self-motivated, and confident
- 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.
- Ability to adapt quickly to new business processes, technologies, and changing business requirements
- Willingness to work collaboratively by incorporating diverse perspectives and appropriately managing relationships in order to strengthen decision-making.
- Entrepreneurial, enjoys working in a fast-paced, small-company environment.
- Flexibility in handling parallel work flows 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.
- 8-10 years industry experience
- Bachelor’s degree in computer science, management information systems, or related field; additional background in life sciences will be favorably considered
- Experience in life sciences, biotech, and/or biopharma is highly desirable, including experience with IT and business operations solutions for nonclinical and translational R&D functions, project and portfolio management, and reporting
- Previous experience in rapidly growing organizations is preferred
- Previous experience with oncology-based big data and cloud computing is desired