(Clinical) Biomarker expert (d/m/w) – Freelance – on hold

Details

Beschreibung

Tasks:

• Supports the pharmacodynamics, prognostic and predictive clinical biomarker strategy implementation
• Provides general technical consultancy in her/his field of expertise (in particular ligand binding based platforms etc. in single-plex and multi-plexing)
• Responsible for the execution / operationalization of work packages in her / his field of expertise such as assay development, validation, transfer, and assay implementation, as well as monitoring biomarker analyses in clinical trials (at external service providers)
• Review of specific analytical biomarker method(s); technical assessment of Service Agreement between external vendors, Quality Assurance and Procurement/Legal (Business Development)
• Developing Biomarker analysis and assessment strategies including evaluation and decision making on selected technology and definition of performance criteria
• Contribution to and review of documents from her/his area of expertise for each specific trial (including but not limited to LSD, LES, CTP, amendments, …);
• 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
• QA-GCP interaction including technical support for CRO audit; interaction/supportive activities for regulatory authorities interaction;
• Support pharmacodynamic data analysis & interpretation
• Support early exploratory biomarker hypothesis testing according to biomarker development plan
• identification, qualification and selection process of external vendors (service providers and suppliers), and the surveillance of selected vendors with appropriate QC data check

Requirements:

• PhD 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 (e.g. CLIA)
• A minimum of 5 years 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
• Proven experience in reviewing clinical trial related documents from his/her area of expertise (e.g. LSD, LES, CTP, CTP amendments)
• English: fluent (verbal and writing)

Additional Information

Location: Darmstadt

Project start: February 2021

Duration: 12 months

Availability: 4-5 days/week

On-site: 10%

Remote: 90%

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