Senior Expert Scientist
Work in a matrix organization in close collaboration with other Translational Medicine functions (DMPK, Preclinical Safety and Diagnostics/Personalized Medicine) to characterize the pharmacological properties of our drug candidates
Represents the Translational Pharmacology function in the Translational Medicine Project Teams May represent the Translational Medicine function in the global Project Teams and lead a Translational Medicine Project Team (core team member).
Manages laboratory-to-human research in Contract Research Organizations: designs, monitors, and reports the primary and secondary pharmacology studies performed
In vitro/in vivo pharmacology compounds selection and profiling, including off target characterization Proof of concept in vivo studies – PK/PD
Identification, method development/validation of clinical pharmacodynamic (PDy) biomarkers Defines and manages the clinical translational PDy analyses (incl. blood and tissue biomarkers), data analyses and reporting according to GCPs and GCLPs
Supports and advises the Clinical Research and Development team
Contributes to the preparation of the pharmacology regulatory documentation (IDB, summaries for IND and IMPD, briefing documentation)
May participate in interactions with Health Authorities.
PhD in relevant expertise area or equivalent in biomedical engineering
Minimum 5 years of experience in Translational Pharmacology Research and drug development Experience working in oncology projects is a must
Experience in the pharma industry
In-depth knowledge in translational research in personalized oncology and basic knowledge of related disciplines including histopathology, bioanalytics, pharmacokinetics and PK/PD
Project management experience and strong communication and presentation skills
Fluent in English