Pharmacometrician

The position is responsible for the development and execution of population pharmacokinetic [PK] and pharmacodynamic [PD] modeling and simulation activities related to the research, design, implementation, data analysis, interpretation, reporting, and publication of studies for products in any phase of development.

Additional responsibilities include the generation and review of pharmacokinetics documents related to regulatory submissions, preparing responses to Agency questions and preparing for and/or attending meetings with Regulatory Agencies or Advisory Committee Meetings.

The position is responsible for supervising and conducting advanced population PK-PD modeling and simulation exercises. Individual advancement is based, in part, on the degree of experience, displaying a progression in the level of expertise and level of independence shown in contributing to drug development and the advancement of science both internally and externally.

Principal Responsibilities:

Within the area of modeling and simulation:

Under minimal supervision:

• Conducts advanced pharmacokinetic (PK)/pharmacodynamic (PD) modeling and simulation research with emphasis on mechanism-based modeling techniques, systems biology and disease progression models.
• Supports product development by defining dose-concentration-pharmacological effect relationships of a drug using modeling & simulation methodologies from data acquired at various development stages (Phase 1-3).
• Performs population PK/PD analyses in support of regulatory submissions.
• Develops & reviews study designs, writes analysis plans & reports, analyses and interprets PK/PD data and results.
• Maintains liaisons within and outside the organization. Represents the organization on scientific matters within the worldwide scientific community.
• Identifies opportunities and ways to address drug development questions/issues.

Competencies and Experience:

• PhD or equivalent in Pharmaceutical Sciences, Clinical Pharmacology, Chemical/Biomedical Engineering or Biological Sciences. With minimum 5-10 years of pharmaceutical development experience in the various aspects of modeling and simulation.
• In-depth knowledge of pre-clinical and clinical pharmacokinetics and PK/PD modeling and simulation principles.
• Fluent in written and spoken English
• Good written and oral communication skills
• Ability to build and maintain effective working relationships inside and outside the department; ability and willingness to work in a cross-functional team environment (building strategic working relationships).
• Ability to multi-task and prioritize assignments, establishing courses of action for self and others to ensure that work is completed efficiently and in a timely manner (planning, organizing and time management)
• Ability to translate creative and innovative approaches into the solution of problems and the timely advancement of projects
• Self motivated with the ability to work independently with minimal supervision (personal accountability)