Senior Pharmacokineticist

Senior Pharmacokineticist

Evotec

Verona, Italy

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 leaning knowledge will be considered as a plus;
  • Provide scientific and operational support to Clinical PK capabilities expansion, including human dose/PK prediction strategies and advanced clinical PK;
  • Excellent communication skills, both written and oral;
  • Excellent problem-solving capabilities and organizational skills.

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