Manager, Clinical Pharmacology Modeling and Simulation
Ph.D. (or foreign equivalent) in Pharmacokinetics, Biopharmaceutics, Clinical Pharmacology, Pharmacodynamics, or a related field. Must know (through coursework or experience) how to: analyze and interpret clinical PK and PK/PD data, including using NONMEM, Winnonlin, SAS/R, and Gastroplus/SimCYP to conduct compartmental and non-compartmental analyses; interpret and report clinical population PK and PK/PD studies; apply statistical concepts and modeling and simulation of data (continuous, categorical, and survival data); apply pharmacological concepts to clinical and preclinical studies.
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Conduct research dealing with the understanding of human diseases by integrating clinical Pharmacokinetic (PK) and Pharmacokinetic/Pharmacodynamic (PK/PD) analyses into clinical development plans and strategies; and provide clinical PK, PK/PD, population PK/PD (e.g. utilizing NONMEM®), and Modeling & Simulation (M&S) contribution to drug development programs as appropriate. Perform the analysis, interpretation, and reporting of clinical PK, PK/PD, and population PK/PD data in addition to preparing clinical PK and PK/PD components of regulatory documents and responses. Provide technical therapeutic and product development support for the company's projects. Ensure optimal application of PK, PD, and M&S principles towards efficient drug development, risk management, and registration of compounds. Ensure the integration of Clinical Pharmacology Modeling and Simulation (CPMS) plans into overall Project and Clinical Development plans and strategies and ensure compliance with all appropriate FDA and ICH guidelines. Work effectively with colleagues in the department as well as others such as statisticians, physicians and drug metabolism scientists. Develop and continuously maintain a strong working knowledge of medical concepts, pharmacology, biology, therapeutics, drug metabolism, bioanalysis, and biopharmaceutics so CPMS principles can be fully and appropriately explored. Develop and maintain contact with internal and external scientific experts so the company's CPMS department remains at the edge of the field. Define clinical PK and PK/PD data aggregation project specifications and the programming environment to implement the tools necessary for data acquisition, transfer, integration, accessibility, pre-processing (in preparation of analysis), and post-processing (to format and present results of the analyses) in a quality controlled and validated environment. Utilize SAS and R programming to deliver real-time access to phase I-IV clinical trial data and analysis-ready data sets and gain timely access to useful external data for clinical drug development. Explore and evaluate novel solutions and tools to increase efficiency in data agreggation, exploratory analyses, and graphic data presentation. Responsible for delivering the data aggregation solutions, exploratory analyses, and graphical data presentation tools within the agreed timelines. Provide expert support to pharmacometrics projects and, more generally, to the project/program teams. Maintain and modify programs and implement approved changes by amending flow charts, developing detailed programming logic, and coding changes. Interact with users to gain understanding of needed changes.
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