- Execution / operationalization of work packages for assay development, validation, transfer, implementation, and monitoring biomarker analyses in clinical trials at external service providers (technology platforms: ELISA, MSD, Luminex, SMC, SIMOA and Flow Cytometry or similar)
- Support of pharmacodynamics, prognostic and predictive clinical biomarker strategy implementation
- Providance of general technical consultancy in the field of expertise (e.g. Flow Cytometry, Ligand binding based platforms etc.)
- Evaluation of (new) technology platforms for their suitability in clinical development and employment in clinical trials
- Development of Biomarker analysis and assessment strategies including evaluation and decision making on selected technology and definition of performance criteria
- Preparation of a dedicated biomarker analytical study plan (review / editing) linked to a specific trial in close collaboration with CBD colleagues and other relevant functions
- Contribution to submitting documents with relevant biomarker content and to the preparation and update of biomarker plans and biomarker prioritization lists in alignment with other relevant functions
- QA-GCP interaction including technical support for CRO audit
- Support of early exploratory biomarker hypothesis testing according to biomarker development plan
- Assessing (and developing) biomarker assays in the light of potential for CDx development (in line with project strategy)
- Identification, qualification and selection process of external vendors (service providers and suppliers)
- Degree in the field of (Bio-)Chemistry, Biology, Pharmacy, Life Sciences or similar (preferably PhD)
- Strong understanding of quality related requirements in drug development and in GXP-related areas and beyond (e.g. CLIA)
- Profound experience in clinical biomarkers and translational research in a pharmaceutical company or equivalent
- Demonstrated hands-on experience in biomarker analysis (cellular, protein and/or small molecule), biomarker assay development and validation and clinical samples testing (technology platforms: ELISA, MSD, Luminex, SMC, SIMOA and Flow Cytometry or similar)
- Proven experience in reviewing clinical trial related documents (e.g. LSD, LES, CTP, CTP amendments)
- Good interpersonal skills, highly self-motivated and proactive
- Fluency in English
- Interesting assignments at renowned national and international companies
- A highly motivated team and an open way of communication
- Support throughout the entire application process
Reference number
521931/1
Contact
Phone:
+ 49 621 1788-4297
E-Mail:
positionen@hays.de