Conceive, execute and communicate multi-disciplinary modeling and simulations exercises to support development plans and strategies to achieve commercial goals and regulatory requirements for multiple functions. Generate new PK/PD modeling and simulation proposals and leads those efforts. Investigate, identify, develop, and optimize new methods and techniques in the field of PK/PD modeling and statistical data analysis. Consistently demonstrates excellent record of accomplishment of Pharmacometric and business objectives. Leads Pharmacometric and PK/PD modeling aspects of multiple projects. Responsible for critically evaluating technical and scientific aspects along with Clinical Pharmacology and Pharmacometrics management.

Responsibilities

• Execute strategy, lead teams and various data analyses and interpretation by providing necessary context (including explaining MoA and disease specifics, available relevant internal and external data, analysis plans, interpretation and discussion of model results in the context of research question).
• Assist Clinical Pharmacology senior management in the selection of action plans that best meet business needs in drug development.
• Author regulatory documents including PK/PD analysis plans, study reports, population PK reports, exposure-response analyses reports, common technical documents, label, white papers, and other similar documents.
• Represent Pharmacometrics in Clinical Pharmacology and clinical project teams and presents in project team meetings and to Clinical Pharmacology Leadership.
• Collaborate with the Clinical Pharmacology TA leads to develop a unified Clinical Pharmacology position.
• Authors scientific publications and present at national and international conferences and interact with external stakeholders.
• Participate in internal and external initiatives/working groups (e.g., process harmonization, IMI calls, ISoP groups).