Stockholm, Stockholm County, Sweden
I am passionate about clinical drug development with a background in oncology research, healthcare, data analysis and communicating medical science. I am looking to support medicinal product development with the aim to make an impact in patients' lives. Personality & Experience: ► Detail-oriented and analytical personality with high Emotional Intelligence. I apply my creative thinking to solve complex issues in clinical trials and assist sponsors to reach study targets and outcomes. ► Project management, coordination, and quality assurance of multiple clinical trials across various therapeutic areas (Oncology, Psychiatry & Depression, Cardiology & ATMP ), as well as experience in submitting applications to authorities (KTA). ► Developed relations with Clinical and Scientific investigators, resulting in 6+ cross-functional collaborations and identified thought leaders (KOLs) as an MSL intern (Combigene AB). ► Leveraged my relationship-building and business awareness to negotiate a better value for laboratory purchases, resulting in significant cost-savings every year (Karolinska Hospital). ► Experienced in design, coordination and managing of scientific projects, formulate hypothesis and analyze data using scientific thinking and problem-solving skills (Karolinska Hospital). My colleagues describe me as being analytical, organized and strategic to reach my goals with a communicative, helpful and diplomatic personality. As a self-motivated Medical Professional I am skilled in: - Molecular Oncology - Dermatological, Adrenal and Gynecologic tumors - Tumor Metabolism and noncoding RNA - Clinical Drug Development, GCP, GLP - Clinical Data Monitoring and Clinical Protocols (CDD course - Uppsala university and UCR) - Influential Communication, Business Awareness and Rapport-building - Emotional intelligent with ability to work individually or in a team - Analytical and Strategic mindset to problem-solving and data analysis - Adept in many Molecular, Cellular and Diagnostic methods gained through my career - Organized approach with Time- and Risk Management skills - Adaptable personality gained through my career journey in different countries and working with people from different backgrounds. Thank you for visiting my profile and feel free to connect.
► On-site/ remote monitoring (SIV/ IMV/ close-out) in phase II, III & IV clinical studies. ► Working knowledge of ICH-GCP, Swedish regulations (HSLF-FS 2021:109) and EU CTR directive 536/2014. ► Submission of clinical trial applications and essential amendments via the CTIS portal. ► Experience in clinical trial planning, protocol writing/ reviewing and project management. ► Trial protocol implementation and communication with sponsors, principal investigators and clinical research coordinators. ► Customer oriented and able to work autonomously. ► Formulate and finalize monitoring reports for sponsors. ► Provide follow-up letters and required measures (Action items) to clinical research sites. ► Manage and coordinate monitoring of clinical study sites in oncology, MS, psychiatry/ depression and ATMP. ► Develop monitoring plans based on risk criteria (RBM). ► Participation in continuous clinical research and development in drug development, Swedish/ EU regulations.
Oncology Knowledge ► Developed solid knowledge in Oncologic diseases (Gynecologic, Neuroendocrine and Skin Tumors) using PubMed alerts and served as a medical resource in my fields. ► Demonstrated expertise in scientific methods to verify and characterize key processes in oncologic diseases regulating cellular functions. ► Developed strong R&D collaborative relationships with Scientific Experts resulting in the completion of research projects in other disease states (Glioblastoma, Cytomegalovirus CMV and Multiple Sclerosis). KOL collaboration Experience ► Developed relationships with local KOLs in Sweden, resulting in collaboration and access to tumor biobank specimens for oncology research projects at Karolinska Hospital. Business Acumen ► Procured laboratory consumables on regular basis, through negotiation with sales representatives resulting in significant cost savings and strong business relationships. Project Management ► Formulated hypothesis and managed research projects from design of experiment (DOE) to execution and generating scientific data for 5 scientific publications while providing team support and managing collaborations. Presentation Experience ► Presented my research findings at 5+ international and local scientific meetings to physicians and researchers resulting in medical and scientific exchange of information. ► Critical appraisal and presentation of clinical and scientific papers at weekly journal clubs resulting in Q&A session experience and leading scientific discussions. ► Presented complex medical and scientific findings at department meetings and on digital platforms.
Identified KOLs and Scientific Experts in Gene Therapy, Neurology, Epilepsy and viral vector production expertise, to support the development of ATMP (Advance Therapy Medicinal Products) gene-therapy-based epilepsy treatment. Adeno-Associated Viral (AAV) vectors are used for Neuro-Peptide Y (NPY) and its receptor Y2 genes delivery to the effected area of the brain. https://combigene.com/en/
Routine Hematology & blood Coagulation analysis, internal & external QC programs, Thrombophilia screening & specialized coagulation tests, ELISA tests, running and maintenance of automated systems, handling of biohazard samples, writing of SOPs. Worked in a GLP facility where I taught visiting students and junior staff. https://deputyprimeminister.gov.mt/en/MDH/Pages/Home.aspx
Low Protein Z levels and the risk of Thrombophilia Protein Z (PZ) is a vitamin K-dependent plasma glycoprotein whose physiological function is still not clearly defined. Studies suggest that protein Z inhibits the procoagulant activity of activated factor X (Xa), in the presence of Ca2+, phospholipids and protein Z-dependent protease inhibitor (ZPI). This will result in down-regulation of coagulation. Reports suggest a connection between PZ levels and thrombotic disorders. Low levels were found to enhance the risk of arterial thrombosis, but not venous thrombosis. A high frequency PZ deficiency was found among women with one early primary fetal loss, predominantly between the 10th and 19th week of pregnancy, whereas perplexing results were reported in ischemic stroke patients. We established a normal reference range from 153 healthy individuals for PZ antigen levels, using Asserachrom PZ ELISA (Diagnostica Stago) and analyzed PZ levels in a group of 52 patients that were divided as follows: Group1: 32 patients who suffered recurrent foetal loss; Group 2: 13 patients who suffered a thromboembolic event; Group 3: 7 patients who suffered an ischaemic stroke. We found that PZ levels have a wide total range with no relationship to age or gender. The mean PZ levels in our patient groups were similar to our control group. In addition, the proportion of PZ deficiency found in the patient groups was similar to that found in normal individuals. We concluded that there is no relationship between PZ levels and the risk of recurrent fetal loss, thromboembolic event or ischemic stroke. Further studies are required to clarify the role of PZ in these thrombophilic states.