Beschreibung
Als renommierte Personalberatung mit Qualitätsanspruch sind wir für namhafte Unternehmen erster Ansprechpartner, wenn es um die Gewinnung qualifizierter Fach- und Führungskräfte geht.Unser Auftraggeber ist ein bekannter internationaler Pharma- und Life Science-Konzern mit Hauptsitz im Rhein-Main-Gebiet. Das Projekt kann zu 90% Remote betreut werden.
Your role:
• 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
Who you are:
• 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)
• English: fluent (verbal and writing)
• 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
Finden Sie sich in der oben genannten Aufgabenstellung wieder und interessiert Sie diese spannende Projektaufgabe in einem namhaften Konzern?
Dann nehmen Sie bitte umgehend Kontakt mit uns auf und bewerben sich unter Angabe Ihres Tagessatzes und Ihrer Verfügbarkeit