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Senior non-clinical PharmacometricianGermany
JOB ID: 194695
JOB LEVEL: Experienced
FUNCTIONAL AREA: Research & Development
You are looking for a great challenge in the field of pharmacometric data analysis in non-clinical PK/PD? You are a good team worker in interdisciplinary international teams? Then we have an interesting job opportunity as a Senior non clinical Pharmacometrician.
Tasks & responsibilities
- You will represent the department Drug Metabolism and Pharmacokinetics in interdisciplinary development teams and in licensing projects and qualifying compounds with regard to their DMPK characteristics. You will be responsible for the authorship for regulatory documents (Investigators Brochure, IND, Submission etc.) in non-clinical development.
- In your new role your main tasks are high quality non-clinical pharmacometric analyses on a project or study level essential for internal decision-making and successful project development.
- You will be responsible for scientific reporting and presentations of non-clinical pharmacometric analyses.
- Representation of non-clinical pharmacometric analyses in project teams and process harmonisation initiatives/workgroups and continuous improvement of non-clinical pharmacometric analyses infrastructure and participation in international / interdisciplinary working groups is one of your key tasks.
- You will also be responsible for a full compliance as a principle investigator for toxicokinetic studies and author of reports in accordance to regulatory pre-requisites.
- PhD in Pharmaceutics, Mathematics, Statistics, Systems Pharmacology, Biology, Medicine, or equivalent area of focus with experience in pharmacometric analyses in pre-clinical or clinical drug development (pharmaceutical industry, academia or regulatory agency).
- Long-term experience in (non-clinical) pharmacokinetic and pharmacodynamic evaluations, pooled analysis, in compartmental and non-compartmental PK/(PD) analysis and compound assessments.
- Proficiency in applying relevant data analysis software (e.g. Phoenix WinNonLin, PKSim, GastroPlus, R) in the area of pharmacometric approaches and PK/PD modelling.
- Ideally knowledge in non-clinical pharmacology and model informed drug discovery and development.
- Understanding of current national and international regulations and local requirements with regard to non-clinical PK development.
- Experience in leading interdisciplinary and international working groups.
- Good written and verbal communication skills in English and German with internal and external partners.
- Good development opportunities with in-house education and various training options
- Healthy and well-balanced food in the canteens and for take away
- Gym and variety of company sports groups
ContactFor further information please contact Recruiting Services:
Mrs. Sarah Geiselmann, Tel: +49 (0) 7351/ 54-175799
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While applying for the job please refer to jobvector and use the following reference number: 194695