Expert Clinical Biomarkers (m/f/d) in bundesweit (Homeoffice)

bundesweit (Homeoffice)
Vollzeit
Pharma
15.04.2021
Expert Clinical Biomarkers (m/f/d) in bundesweit (Homeoffice)

adesta - success is our attitude

adesta sees itself as a partner for customers as well as for employees and applicants. Each appreciate the high-quality, individual advice and support which they receive at adesta.

On behalf of our client, a world-renowned pharmaceutical and life science enterprise with headquarters in Darmstadt, we are looking for a


Expert Clinical Biomarkers (m/f/d) in bundesweit (Homeoffice)

  • Support the pharmacodynamics, prognostic and predictive clinical biomarker strategy implementation
  • Provide general technical consultancy (in particular ligand binding based platforms etc. in single-plex and multi-plexing)
  • Responsible for the execution / operationalization of work packages 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 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
  • 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

Are you interested in this challenging job? Then please submit your profile under specification of reference number 29-302-12968. If you have any questions, please do not hesitate to contact Mr. Jungclaus.


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