The Associate Director, Pharmacometrics will act as an internally and externally recognized pharmacometrician by driving pharmacometrics (PMx) strategy, performing PMx analyses and representing PMx in project teams. They will continuously and consistently develop, implement, and promote innovative PMx methodologies/approaches and provide consultancy and expert advice to other stakeholders. Develop PMx strategy for projects and indications.

Responsibilities

• Drive Pharmacometrics PK/PD strategy across multiple major projects and programs; collaborate with CPPM senior management in the selection of action plans that best meets business needs in drug development
• Responsible for the appropriateness, quality and accuracy of pharmacometrics deliverables
• Advise on complex methodologies such as advanced analytics, machine learning and mechanistic modeling
• Ensure the timely delivery of PMx regulatory documents and response to regulatory agency comments
• Contribute to development of departmental goals; influences strategic PK/PD decisions for the department
• Maintain up-to-date knowledge of industry standards in PK/PD data analyses, modeling and simulation methods and software
• Represent Pharmacometrics in core team meetings
• Champion development, implementation, and promotion of innovative PMx approaches across therapeutic areas; identify and develop process improvement initiatives
• Participate in internal and external initiatives/working groups (e.g., cross-functional initiatives, process harmonization, IMI calls, ISoP groups)
• May manage personnel including their development, mentoring, and effective delegation