Darmstadt | Employment with Hays Professional Solutions GmbH
Reference number
Start date
My duties
  • 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)
My qualifications
  • 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
My benefits
  • Interesting assignments at renowned national and international companies
  • A highly motivated team and an open way of communication
  • Support throughout the entire application process
About Hays
With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.
My contact at Hays

Reference number

Phone: + 49 621 1788-4297
E-Mail: positionen@hays.de