Senior Pharmacokineticist Verona

Senior Pharmacokineticist
Verona
Veneto, Verona

Job Profile Objective and Purpose of the Role The aim of this role is to perform all types of pharmacokinetic and pharmacodynamic analysis (PK/PD) e. g. non-compartmental PK, compartmental and population PK and PK/PD, to support clinical studies, including translational PK/PD analysis.

Qualified candidates will have the ability to work on a variety of therapeutic indications and data types with an adequate understanding of applied population PK and PK/PD modeling and simulation to support drug development programs.

Key Responsibilities Plan and perform appropriate analysis (e. g. non-compartmental, population and/or modeling and simulation analysis of PK and/or PD data) of clinical data, dose/exposure-response relationships, to guide dose regimen and optimize study design. Summarize and provide interpretation of results of PK and PK/PD analyses with respect to their impact on a development program and clinical use. Development of translational PK/PD models to support clinical studies. Work closely with multidisciplinary project teams to develop and implement semi-mechanistic mathematical models of pharmacological processes. Carries out functional responsibilities in accordance with applicable SOPs, regulatory requirements (GLP and GCP) and company Policies, maintaining high level of quality and reliability in all work conducted. Provide scientific and operational support to Clinical PK capabilities expansion, including human dose/PK prediction strategies and advanced clinical PK. Technical Competencies, Education and Skills MSc in pharmacology, bio/engineering, pharmacokinetics/pharmacodynamics, Mathematics or equivalent disciplines. PhD in relevant discipline (pharmacology, bio/engineering, pharmacokinetics/pharmacodynamics, etc. ) will be considered as a plus. A minimum of 1 to 3 years of industry/consulting experience (may be combined with academic research) working in R&D, pre-clinical and clinical environments. Experience in using modelling and simulation packages such as Monolix, R, NONMEM. Proficiency in software used for clinical non-compartmental analysis (NCA) - Phoenix Winnonlin. Proficient in spoken and written English. Knowledge of PBPK models and use of PBPK software (e. g. Gastroplus, PKsim) will be considered as a plus. Machine learning knowledge will be considered as a plus. Excellent communication skills, both written and oral. Excellent problem-solving capabilities and organizational skills.

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