Beschreibung
* Support of pharmacodynamics, prognostic and predictive clinical biomarker strategy implementation (protein-based)* Execution and operationalization of work packages, for example in assay development, validation, transfer, implementation and monitoring biomarker analyses in clinical trials
* Evaluation of technology platforms for their suitability in clinical development and employment in clinical trials
* Review of specific analytical biomarker methods
* Technical assessment of Service Agreement between external vendors, Quality Assurance and Procurement/Legal
* Developing Biomarker analysis and assessment strategies
* Preparation of a dedicated biomarker analytical study plan linked to a specific trial
* Collaboration with CBD colleagues and other relevant functions
* Vendor surveillance and quality control
* QA-GCP interaction including technical support for CRO audit
* Interaction and support for regulatory authorities interaction
* Ph.D. or MD degree or equivalent in the field of (Bio-)Chemistry, Biology, Pharmacy, Life Sciences or similar
* Strong understanding of quality-related requirements in drug development and in GXP-related areas and beyond (GCP and GLP)
* Experience in clinical biomarkers and translational research in a pharmaceutical company or equivalent
* Demonstrated hands-on experience in biomarker analysis, biomarker assay development and validation and clinical samples testing
* Experience in reviewing clinical trial related documents (e.g. LSD, LES, CTP, CTP amendments)
* English: business fluent, German: nice to have
Schlagwörter:
Vendor Management, Bioanalytisch, Bioanalyse, Ligand Binding, Luminex, Elisa, proteinbased, Biomarker, Analyse, GxP, Krebsforschung, Onkologie, Krebs, Medikamentenentwicklung, Medikamente, Entwicklung, onkologisch, Pharmazeut, Biologe, Cancer
Kontaktperson: Personalreferentin Frau Julia-Elisabeth Kratz
FERCHAU GmbH
Niederlassung Darmstadt
Rösslerstr. 88
64293 Darmstadt