Beschreibung
Are you an expert in pharmacokinetics and pharmacodynamics? Then you are the right person for this job!We are searching a Ph. D. level Scientist (m/f) for our biotech-client in Bavaria on a freelance base:
Ph. D. level Scientist (m/f) who is driven to understand the pharmacokinetics and pharmacodynamics of novel drug candidates in the area of Oncology and Immunology.
Responsibilities:
- You will be responsible for the PK/PD activities on Biologics in clinical development. This will be accomplished by working in close partnership with Clinicians and the project teams.
- You will participate in project teams as well as interface with preclinical PK/PD.
- Your responsibilities will include planning and reviewing study designs, analysis plans, data analysis and interpretation of PK/PD data as well as presentation of data in cross-functional teams, department meetings, conferences and regulatory meetings.
Requirements:
- Relevant experience in drug development is expected and experience with pharmacokinetic analysis of Biologics is highly desired.
- Familiarity with quantitative approaches in drug development, working knowledge of modelling software and the ability to plan, organize, and critically assess and/or perform PK/PD data analyses are essential. In addition, good knowledge of GCP and regulatory guidelines is desirable; experience in the preparation of regulatory applications (IMPD/IND, BLA, CTD) would be a plus.
- You must have excellent communication skills and the ability to work effectively on interdepartmental project teams. Your education should be a Ph. D. or equivalent in Pharmacokinetics, Life Sciences, Biomedical Engineering or related discipline, at least 2 years or more of industry experience is highly desired.
- Fluency in scientific and business English is a must, some basic knowledge of German is appreciated, but not compulsory for the position.
Startdate: asap
Volume: full-time (40h/ week)
Duration: 3-6 month
Location: Bavaria
Are you interested in this Project? Please deliver your CV in Word-Format.
Best regards,
Stefan Blöchl
Tags: pharmacokinetics, pharmacodynamics, drug development, Preclinical, Scientist, Pharmazie, Pharma, Medizin, Freelance, freiberuflich, befristet, Medical, Biologie, Onkologie, Orphan, drug, Master, Bachelor, GCP, GxP, Clinical, CRO, Studien, klinisch, TMF, Prüfplan, Prüfbogen, Monitor, CRA, CTA, Trial Master File.