Life Sciences Consultant
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- 82131 Gauting
- Weltweit
- en | da | de
- 18.11.2024
Kurzvorstellung
LIMS/ELN selection and design; Biomarker validation and development; Trial Set Up; Project Management; Vendor Management & Outsourcing
Labs:
M&A; ISO/CLIA; IVDR; BizDev; LIMS set up; Assay Development
Qualifikationen
Projekt‐ & Berufserfahrung
8/2023 – 12/2023
Tätigkeitsbeschreibung
• Leading vendor selection, evaluation, contracting and set up process (sponsor side)
• Provide strategic input for senior team to ensure sustainable processes are established for clinical development
• Establishing SOPs for vendor (CROs, central labs, etc.) oversight, KPI monitoring and other vendor oversight processes.
• Coaching clinical operations team to ensure industry standard delivery and compliance with international standards.
• Hands-on clinical operations set up for Phase I and Phase II CART cell studies.
Gute Klinische Praxis, Gute Laborpraxis (GLP)
7/2023 – offen
TätigkeitsbeschreibungGeschäftsführer
Eingesetzte QualifikationenGute Klinische Praxis, Gute Laborpraxis (GLP)
2/2018 – 4/2023
TätigkeitsbeschreibungOversight and responsibility management and growth of several departments, including Vendor Management, Laboratory Support Services, Supply Chain Management (CMOs), eCOA, Depots, Equipment Supply and Import/Export.
Eingesetzte QualifikationenGute Klinische Praxis, Gute Laborpraxis (GLP), Klinische Forschung, Medizintechnik, Supply-Chain-Management (SCM)
6/2016 – 9/2016
TätigkeitsbeschreibungResponsible for preclinical in vivo testing and the management of CROs
Eingesetzte QualifikationenEnterprise project management (EPM)
12/2012 – 7/2016
TätigkeitsbeschreibungLabordirektor
Eingesetzte QualifikationenGute Klinische Praxis, Gute Laborpraxis (GLP)
Ausbildung
Oxford University
Sussex University & Tübingen University
Über mich
Track record delivering complex high throughput biomarker discovery/testing in Pharma, Academia and Diagnostics.
Accomplished team builder with excellent staff retention and re-recruitment. Background in drug discovery and validation of biomarkers, assay development, clinical molecular pathology/haematology, personalized medicine, in vitro and in vivo assay development, GCP, GLP and GxP.
Weitere Kenntnisse
Pharma and Biotech:
• LIMS/ELN selection and solution design
• Biomarker validation and assay development
• Clinical trial planning and set up
• Vendor selection, qualification and management (CRO, CMO, central and specialty labs)
Labs:
• Mergers and acquisitions
• Restructuring and Business Plans
• LIS/LIMS
• Assay development
• ISO/CLIA accreditation, including QMS review, internal and external audits
• Readiness for IVDR transition
Persönliche Daten
- Englisch (Muttersprache)
- Dänisch (Muttersprache)
- Deutsch (Fließend)
- Europäische Union
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