• Senior / Principal PBPK Modelling Jobs in Germany

  • Boehringer Ingelheim India Pvt Ltd
  • Germany
  • Save Job
  • 0 - 3 Years
  • Posted : above 1 month

Job Description:

Boehringer Ingelheim (BI) is expanding its global Pharmacometrics (PMx) group in Biberach, Germany

BI PMx applies a question-based fit-for-purpose approach to inform drug development with state-of-the-art PMx approaches that include but are not limited to non-linear mixed effects models, physiological-based pharmacokinetic models (PBPK), and quantitative systems pharmacology (QSP) models

As a PBPK modelling expert, you will drive the implementation of PBPK modelling approaches within the department of Translational Medicine and Clinical Pharmacology Focusing on clinical pharmacology relevant topics such as DDI, pediatric scaling, absorption modelling, tumor distribution you will further the mechanistic understanding of ADME processes of small and large molecules You act as a key contributor to the multi-disciplinary drug development effort working closely together with experts in the fields of medicine, clinical pharmacology, drug metabolism and pharmacokinetics, research, pharmacometrics and clinical development

Together with our project pharmacometricians you will to drive the implementation PBPK approaches in clinical development projects forward and support internal as well as external initiatives focusing on the application, model development/qualification, documentation and training of PBPK approaches

Tasks & responsibilities as Senior PBPK Modelling Expert As PBPK modelling expert you support project pharmacometricians and clinical development teams when implementing PBPK analyses to guide experimental/ study design towards data generation and support dose selection/ labelling with respect to clinical pharmacology topics
You represent PMx in internal working groups (eg pediatric development, IVIVc) and external initiatives (eg OSP, process harmonization, IMI calls)
You contribute to the development of good practice documents/ white papers in the area of PBPK
Proactively you plan, perform, present and report PPBK analyses in close collaboration with other key functions and act as co-author internal and regulatory relevant documents
With an innovative mindset you contribute to the improvement of the the PMx IT infrastructure (eg standardization efforts) and evaluate and implement new methods and software
Moreover, you identify and document relevant data (literature, in vitro, in vivo, clinical trial data) for model optimization, evaluate and apply text/data mining tools

Tasks & responsibilities as Prinicpal PBPK Modelling Expert You take over the leading role for the development of good practice documents/ white papers in the area of PBPK
You lead analysis teams, initiatives and workgroups (internally or externally) for PBPK modelling across projects or specific applications to clinical development

Requirements PhD in Medicine, Pharmaceutics, Mathematics, Statistics, Systems Pharmacology, Clinical Pharmacology or equivalent area of focus with experience in pharmacometrics in pre-clinical or clinical drug development (pharmaceutical industry, academia or regulatory agency)
Comprehensive PBPK modelling experience across different applications in (pre-)clinical drug development
Demonstrated competence with relevant data analysis software such as PKPB software, R, MATLAB, SimBiology
Proficient knowledge in clinical pharmacology and model informed drug discovery and development (MID3)
Demonstrated consistent high quality MID3 contributions to clinical drug development projects at different phases of clinical drug development (strategic and operational)
Creative and open minded personality with an analytic, proactive, goal orientated way of working
Excellent interpersonal skills and the ability to collaborate successfully with teams across the organization (global, multicultural and in virtual teams)

Additional requirements for a Principal Position Successful track record in leading across-project initiatives (internal/external) in cross-functional teams to implement and promote PBPK modelling in drug development
Demonstrated expertise in leading development of best-practice documents, training of (non-)pharmacometricians, standardization or implementation of new methods or Software

Our benefits

Good compatibility of work and private life

Profile Summary:

Employment Type : Full Time
Eligibility : Any Graduate
Industry : Biotechnology/Pharmaceutical/Medicine, Manufacturing/Industrial
Functional Area : Teaching/Education
Role : Teacher
Salary : As per Industry Standards
Deadline : 08th Mar 2020

Key Skills:

Company Profile:

Boehringer Ingelheim India Pvt Ltdarfix

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