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

  • Position zu besetzen ab 1. Februar 2021
  • Permanent-ID OCR-FL-1161
  • Branche Pharma
  • Beschäftigungsform Freelance/ Contracting
  • Standort Deutschland / 6x
  • Kategorien Beschäftigungsform, Branche, Freelance/Contracting, Pharma

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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