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EDUCATION:

• A minimum of a Bachelor’s degree is required
• Advanced degree (Master’s, PhD) in Pharmaceutical Sciences, Clinical Pharmacology, Pharmacometrics, Chemical/Biomedical Engineering or Biological Sciences is highly preferred

The Principal Scientist, Pharmacometrics position is responsible for the co-development and execution PK/PD Modeling and Simulation activities related to the research, design, implementation, data analysis, interpretation, reporting, and publication of ClinPharm supported studies for products in any phase of development. Additional responsibilities include the generation and review of clinical pharmacology documents related to regulatory submissions, preparing responses to Agency questions and preparing for and/or attending meetings with Regulatory Agencies and Advisory Committee Meetings.
The position is responsible for contributing to conducting advanced research (e.g., model-based population PK and PK/PD drug development). Individual advancement is based, in part, on the educational background, degree of experience, displaying a progression in the level of expertise and level of independence shown.

You will be responsible for :

• Conducting advanced pharmacokinetic (PK)/pharmacodynamic (PD) modeling and simulation research with an emphasis on mechanism-based modeling techniques, systems biology and disease progression models.
• Supporting 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).
• Performing population PK/PD analyses in support of regulatory submissions.
• Developing & reviewing study designs, writing analysis plans & reports, analyzing and interpreting PK/PD data and results.
• Identifying opportunities and ways to address drug development questions/issues that qualify to be addressed with linear or nonlinear mixed effects modeling.
• Serving as a technical expert in the application of PK/PD modeling theories, concepts, principles and processes.
• Maintaining liaisons within and outside the organization. Representing the organization on scientific matters within the worldwide scientific community.
• Helping to advance the science in the field, identifying and coordinating research collaborations with external parties
• Participating in and/or expanding knowledge of pharmacometrics and related sciences via internal/external presentations, trainings, educational events, and/or meetings

• Carrying out functional responsibilities in accordance with applicable SOPs/Guidelines and Regulatory requirementsAssisting in process improvement initiatives and SOP/Guideline development