Giessen, Hesse, Germany
Enthusiastic and self-motivated clinical researcher with 10+ years’ hands-on experience in scientific/clinical project management. A team leader with excellent verbal and written communication, and certified knowledge of GCP guidelines and other regulatory requirements. Proven expertise in the areas of infectious and rare/pulmonary disorders.
Key Accountabilities: • Initiate, plan, manage and close out of Phase I and II projects with all departments including external vendors and external units as required • Project communication with sponsor, internal team and external vendors • Continuous reporting and update of project progress including communication internally and with sponsor and external vendors • Budget control for Phase I and II studies including: - Service inquiries with external vendors - Budget and contract negotiation with sponsors and external vendors - Forecasting, tracking and invoicing • Responsible for core team meetings with sponsor, internal team and external vendors • Responsible for the setup of project specific training in company system
• Design and conduct pharmacology studies (Protein purification and nanodisc technology), • Support laboratory staff including students and technical assistants, • Teaching activities: Head of the Course “Research4Vets” in the Institute of Pharmacology and Toxicology, FB10 (Veterinary Medicine, 5th and 7th Semester) - Seminar: Laboratory Methods in the Biomedical Research - Modul1, - Training: Experimental Methods of Pharmacology and Toxicology – Modul2, - Lab-Rotation: Practical training, Lecturer of “Special Pharmacology” (Veterinary Medicine, 8th Semester) - Diabetes Mellitus, Lecturer of “Special Toxicology” (Veterinary Medicine, 5th Semester) - Test procedures in Toxicology, Lecturer of “General Pharmacology and Toxicology” (5th Semester) at the Institute of Pharmacology and Toxicology, Faculty of Veterinary Medicine, JLU - Pharmacodynamics: - Signal Transduction and Receptor classes, - G-Protein-coupled receptors, - Receptors with kinase activity and nuclear receptors (in 2020).
• Prepare and deliver lectures about Pharmacodynamics and Signal transduction: - Receptor classes and signal transduction, - G-Protein-coupled receptors, - Receptors with kinase activity and nuclear receptors, Special Toxicology: - Methods in toxicology, Special Pharmacology: - Diabetes mellitus, Laboratory methods in biomedical research, • Design and conduct pharmacology studies (Protein purification and nanodisc technology), • Support laboratory staff including students and technical assistants.
• Study site management including, but not limited to, site/investigator identification, qualification, selection, initiation, routine monitoring, close-out and maintenance according to GCP requirements (Poland, Austria and Switzerland) • Regulatory Affairs: - Communication with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, clarification and follow-up of submissions under review (Poland), - protocols and PIS/ICF amendments (Germany and Poland) • pCRF and eCRF design, testing and maintenance
Face-to-face practical sessions and advanced hands-on training on: • Regulatory affairs (ICH E6 (R2), 2001/20/EC, 2005/28/EC and 536/2014), • Conducting clinical trials (Essential Documents, monitoring, audits and inspections), • Logistics (Clinical Trial Supply, GMP, QM and PM in Clinical Logistics), • Clinical data management (IVRS, CRF, Data validation, etc.).
Principal Investigator - "Extracellular enolase-1 as a therapeutic target in idiopathic pulmonary fibrosis“ (UKGM grant; Projekt Nr.: 22/2016 GI): • Oversee project design & management, • Provide expertise in the fields of oncology and lung pathophysiology • Set up collaborations & handle multi-institutional interactions, • Write annual reports, scientific publications & research grant applications, • Train, support and lead Ph.D. students & technical assistants, • Present research data to the global audience on internal & international meetings. Projects: "Extracellular enolase as a protease cofactor in cancer and inflammatory cell invasion." "Infection and innate immunity of the lung: Role of extracellular nucleic acids." "Role of proteases and associated receptor systems in the pathogenesis of lung diseases".
Highly competitive "Start-up fund" from the ECCPS Project: "The role of protein arginine methyltransferase (PRMT) 1 in the pathogenesis of idiopathic pulmonary fibrosis (IPF)" Other Projects: "The molecular mechanism of enolase-1 translocation under stimulatory conditions in cancer cells" "The role of extracellular RNA and RNA-binding proteins in lung infection and inflammation" "Involvement of protein arginine methylation in the pathogenesis of chronic lung diseases"