Partner closely with the scientists in Clinical Pharmacology and Pharmacometrics (CP&P) to understand their information technology and digital enablement needs. Formulate CP&P IT strategy, based on internal and external input, and alignment with overall R&ED IT strategy which result in roadmap and budget for strategic and operational programs. Work closely with the matrix IT organization to provide domain expertise, take overall accountability for the successful execution of the programs and projects
- Exceptional communication and relationship building skills to establish strong partnership, trust and rapport with senior leaders and scientists in CP&P
- Recognized as a thought leader and trusted advisor in CP&P IT; Influences the strategic thinking of senior business leaders and helps business leaders to include future digital capabilities into their planning; perceived as a capable leader who plans and delivers digital capabilities, safeguards their digital assets and supports their strategic goals.
- Identify and articulate use cases, gather requirements and transform them into digital solutions with the respective team members.
- Leverage analytical skills to facilitate the design of data models, data standards and analysis tools for the CP&P community as well as other key stakeholders.
- Drive the development of realistic and actionable multi-year strategic digital capability roadmaps, informed and prioritized by business and IT in an enterprise context.
- Lead the prioritization and development of strong and clear business cases for digital capability investments in support of the roadmap and aligned with the platform strategy
- Articulate the need of CP&P business functions to appropriate IT groups including Enterprise Information Management, Business Intelligence and Analytics, domain/enterprise architecture and to ensure that integrated, scalable and scientifically robust solutions are implemented
- Drive change - ensures effective planning, execution and communication of business change management to support digital capability investments, including business process changes to achieve maximum value from investments.
- Build proposals for technology capabilities supporting technology solutions for CP&P that meet near-term and long-term needs and define detailed requirements for those capabilities.
- Own the ultimate delivery of value to the scientific user base. Responsible for building and managing effective business partnership at all levels during project execution. Fully accountable for delivering the value proposition of IT.
- Provide project management leadership where necessary. Empowers build & run teams: Understands IT business partner accountabilities throughout the plan/build/run cycle and builds empowered and trusting partnerships with IT build &run team members at all levels.
- Ensure that the Digital Delivery teams make the right trade-offs between speed, quality and cost and that the value is being captured from the entire lifecycle of the IT investment
Key Business Partners:
- Clinical Pharmacology and Pharmacometrics
- Early Clinical Development
- Enterprise Information Management
- Enterprise Architecture
- R&ED DCMs
- Project and Portfolio Management
- MS or PhD or advanced scientific degree, in one of the following:
- Pharmaceutical sciences, mathematics, statistics, basic sciences, computational sciences, biomedical informatics, research informatics, or related areas with deep expertise in relevant informatics/IT platforms and solutions
- Must have deep understanding of scientific understanding of pharmacology and pharmacometrics
- Extensive experience with Quantitative Systems Pharmacology (QSP) and PBPK systems
- The ideal candidate will possess a minimum of 7 to 10 years of proven experience in support of QSP, PBPK environments.
- Must be proficient in some or all of the following: Phoenix Win Nonlin/NLME, R, S+, SAS, NONMEM, Matlab/Simbiology Must be familiar with Computer Systems Validation as well as Good Laboratory Practicer (GLP)/ Good Clinical Practices (GCP) and 21 Code of Federal Regulations (CFR) Part 11 regulations.
- Experience in creating a digital strategy for Clinical Pharmacology and Pharmacometrics
- Demonstrated success in cultivating and maintaining successful working relationships across matrix organizations.
- Demonstrated success in delivering complex solutions following appropriate Software Development Life Cycle (SDLC) methodology and Agile software development
- Ability to work in a highly matrixed organization
- Excellent written and verbal communications skill