Life Sciences Consultant

12/2023 – 12/2024

Vaccines Clinical Studies
• Authoring Biomarker planning documents, biomarker manuals,
research and development reports
• Review of clinical reports
• Development of standard operating procedures and
interdepartmental training materials

Wissenschaftlicher Medizinforscher

8/2023 – 5/2026

• Phase I, II & pivotal studies in EU, US & APAC in B cell lymphomas (including DLBCL, ALL) and inflammatory diseases (SLE, MS, etc.) for adult and paediatric populations.
• Coaching clinical teams and project managers to ensure compliance with national and international standards (CTR, GDPR, IVDR, GCP/GLP, CDx, etc.)
• Delivery of oncology and inflammatory disease clinical trial protocols with a focus on patient centricity and welfare
• Guidance and document generation during regulatory authorities’ interaction (e.g. CTIS) process
• Lead vendor selection, assessment, RFPs, contracting, trial set up and management for CAR T and medical device trials (CROs, Central Labs, Imaging, CTAs, etc.) with a focus on minimizing cost of delivery
• Delivered KPIs & QTLs to manage risk and ensure timelines are met
• Facilitated translational sciences to progress pre-clinical biomarker concepts to clinical trials for oncology and inflammatory diseases (i.e. selection, development and validation of biomarker assays including Immunogenicity, PK/PD strategies)
• Provide strategic input for senior team to ensure sustainable (efficient) processes are used for clinical development
• Vendor qualification audits
• Developed SOPs for biomarker strategy, lab management, sample management, vendor audits (CROs, central labs, imaging, eCOA, etc.), qualification, oversight, KPI monitoring, vendor oversight processes, including risk mitigation.

Gute Klinische Praxis, Gute Laborpraxis (GLP)

7/2023 – offen

Geschäftsführer

Gute Klinische Praxis, Gute Laborpraxis (GLP)