Beschreibung
Tasks:Supports the pharmacodynamics, prognostic and predictive clinical biomarker strategy implementation
Provides general technical consultancy in her/his field of expertise (e.g. Flow Cytometry, 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, implementation, build-up / use of new technology platforms and monitoring biomarker analyses in clinical trials (at external service providers)
Evaluation of (new) technology platforms for their suitability in clinical development and employment in clinical trials
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
Contributes to submission documents with relevant biomarker content; Contribution to the preparation and update of biomarker plans and biomarker prioritization lists in alignment with other relevant functions; Review of aforementioned documents.
Vendor surveillance and quality control
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
Qualification:
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)
English: fluent (verbal and writing)
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)
Good interpersonal skills, highly self-motivated and proactive
Good presentation and communication skills;
Skilled to organize, coordinate or operationalize while maintaining flexibility
Distill complex issues and clearly articulate/present solutions
Frame Data:
Start: End of January, latest 15.02.2021
Dauer: min. 12 months
Capacity: full-time, 90-100% remote