Subject Matter / Protein based Biomarker Assays

Firmenname für PREMIUM-Mitglieder sichtbar

  • Mai 2021
  • nicht angegeben
  • D-64293 Darmstadt
  • auf Anfrage
  • 11.04.2021
  • FR53-03678-DA

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Projektbeschreibung

Aufgabe:
* 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

Voraussetzungen:
* 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

Eintrittsdatum: 01.03.2021
Dauer: 48 Wochen

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