Gaiberg, Baden-Württemberg, Germany
Senior Clinical Data Scientist & Biomedical Curator | Bridging Molecular Neuroscience & Precision Oncology for Clinical Development For over 11 years, I have served as the scientific authority for the functional interpretation and curation of >50,000 clinically relevant germline and somatic variants at Molecular Health. My work directly supports patient stratification and matching for Phase II–III clinical trials, real-world evidence generation, and regulatory-grade decision-making in oncology and precision medicine. I combine deep biological expertise (PhD Molecular Biology, Neuroscience) with advanced automation to deliver structured clinical data review, harmonization, and ETL processes equivalent to medical monitoring and data review. By designing and implementing LLM-powered curation pipelines, I reduced manual effort by >80 % while maintaining IVDR-compliant data quality and reproducibility — accelerating clinical data delivery for trial recruitment and inspection readiness. Core Expertise • Scientific oversight of clinical-trial data (lab data and eligibility criteria) • Development and maintenance of structured, literature-derived knowledge bases feeding Molecular Tumor Boards and clinical decision-support tools • End-to-end data governance, QA/QC standards, and structured data extraction/harmonization • Scientific Liaison & KOL engagement (Japan 2018–2020): KOL training, JSMO presentations, and stakeholder mentoring My pragmatic, quality-driven, and collaborative working style — rooted in academic rigor yet focused on pragmatic execution — makes me a strong scientific partner in a global environment where rigorous clinical data oversight, continuous improvement in data quality and automation, and true scientific partnership create measurable impact for patients. The curious kid in me still hunts for the next mechanism and the next hidden pattern. The disciplined curator ensures those insights become robust, inspection-ready, and actionable. Open for meaningful conversations — especially with forward-thinking teams.
Led end-to-end biomedical content curation with deep focus on clinical oncology, variant classification and biomarker evidence, creating structured, high-quality knowledge summaries for clinically actionable datasets in precision medicine. Designed and co-developed LLM-based solutions to optimize curation workflows, including automated Clinical Variant Information (CVI), PubMed relevance scoring, and intelligent alert systems. Collaborated with a Deep Neural Networks specialist (now at Google) on an ML/DNN-based publication retrieval project: curated and provided high-quality training data and performed rigorous cross-validation to ensure model accuracy and relevance. Owned clinical trial data extraction and integration in close collaboration with IT and product teams. Conducted systematic quality assurance, data harmonization, tool validation (MH Guide, CurING) and compliance checks (IVDR) to guarantee highest data reliability for regulated medical products. Served as Scientific Liaison Manager for Japan (2018–2020): Delivered presentations at JSMO conferences (Kobe & Kyoto) and provided expert consultancy to medical reviewers. Co-developed automation tools that reduced manual curation time by more than 80% while significantly increasing data quality and scalability. Publication (selected): Consolidated BRCA1/2 Variant Interpretation by MH BRCA Correlates with Predicted PARP Inhibitor Efficacy Association by MH Guide. Hirotsu Y, Schmidt-Edelkraut U, et al. Int J Mol Sci. 2020 May 29;21(11):3895. PMID: 32486089
Project: Adult Neuronal Stem Cells (PD Dr. Francesca Ciccolini) Bone Morphogenetic Protein Promotes Lewis X Stage-Specific Embryonic Antigen 1 Expression Thereby Interfering with Neural Precursor and Stem Cell Proliferation. Luque-Molina I, Khatri P, Schmidt-Edelkraut U, Simeonova IK, Hölzl-Wenig G, Mandl C, Ciccolini F. Stem Cells. 2017 Dec;35(12):2417-2429. PMID: 28869691 γ-Aminobutyric A receptor (GABA(A)R) regulates aquaporin 4 expression in the subependymal zone: relevance to neural precursors and water exchange. Li Y, Schmidt-Edelkraut U, Poetz F, Oliva I, Mandl C, Hölzl-Wenig G, Schönig K, Bartsch D, Ciccolini F. J Biol Chem. 2015 Feb 13;290(7):4343-55. PMID: 25540202
Project: Epigenetics and Neuronal Stem Cells (PD Dr. Dietmar Spengler) Imprinted Zac1 in neural stem cells. Daniel G, Schmidt-Edelkraut U, Spengler D, Hoffmann A. World J Stem Cells. 2015 Mar 26;7(2):300-14. PMID: 25815116 (Review) Roles of imprinted genes in neural stem cells. Hoffmann A, Daniel G, Schmidt-Edelkraut U, Spengler D. Epigenomics. 2014;6(5):515-32. PMID: 25431944 (Review) Zac1 regulates cell cycle arrest in neuronal progenitors via Tcf4. Schmidt-Edelkraut U, Daniel G, Hoffmann A, Spengler D. Mol Cell Biol. 2014 Mar;34(6):1020-30. PMID: 24396065 Zac1 regulates astroglial differentiation of neural stem cells through Socs3. Schmidt-Edelkraut U, Hoffmann A, Daniel G, Spengler D. Stem Cells. 2013 Aug;31(8):1621-32. PMID: 23630160
Project: Hibernation and tau phosphorylation (Prof. Dr. Wolfgang Härtig) Hibernation model of tau phosphorylation in hamsters: selective vulnerability of cholinergic basal forebrain neurons - implications for Alzheimer's disease Wolfgang Härtig, Jens Stieler, Ate S Boerema, Jennifer Wolf, Udo Schmidt, Jana Weissfuss, Torsten Bullmann, Arjen M Strijkstra, Thomas Arendt Eur J Neurosci. 2007 Jan;25(1):69-80. PMID: 17241268