Carola Schmidt
Translational Imaging Lead @Bayer
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WORK HISTORY
Translational Imaging Lead @Bayer
Toronto, ON, CA
Takes end-to-end ownership of all aspects of imaging delivery in synchronization with the drug R&D process, informed by deep understanding of clinical development in Oncology and state-of-the-art imaging strategies including the use of biomarkers•Responsible for assigned development programs (Phase I - IV; e.g, TRT, imaging agents, IO, antiandrogen) with regards to advising on appropriate use of imaging biomarkers and techniques and on the appropriate implementation in clinical trials (dosimetry, imaging acquisition and analysis techniques, imaging documents including charters, image collection, quality control and archiving; IB); actively contributes to study design and protocol development, operational implementation of imaging strategy or regulatory interactions.•Serves as a member of the Integrated Product Team (IPT) and proactively provides relevant Oncology expertise to IPT when evaluating and developing imaging strategies •Acts as thought partner to early research leaders, proactively following early projects prior to D2, and taking an active role from D2 onwards, assembling resources for subsequent imaging activities on the project•Independently identifies new opportunities for collaboration and manages excellent relationships with new and existing partners, both within as well as outside of Bayer, to drive Imaging excellence•Provides expertise relating to regulatory framework for biomarkers, and use of imaging for registration of Oncology products.•Responsive to clinical teams during the course of design, execution and interpretation of imaging trials
EDUCATION
CRA School of Montreal, Canada
Clinical Research Professional
Academy of Applied Pharmaceutical Sciences
Post-Graduate Certificate Program in Clinical Research, Drug Safety and Pharmacovigilance
RPTU Kaiserslautern-Landau
Master of Arts (M.A.), Management of Healthcare Facilities
University of Duisburg-Essen
German State Exam, Medicine
ABOUT CAROLA SCHMIDT
A seasoned pharmaceutical and medical imaging specialist (MD) with 10 years experience, an expert in aligning medical knowledge, safety and quality. I have been fortunate to transform human health in various ways: through the application of state-of-the-art imaging technologies, by managing therapy-related adverse events as well as by fostering innovation through research and contribution to cutting-edge technological developments (AI). Over the years I have worked in diverse healthcare settings as well as in the biopharmaceutical industry in close collaboration with cross-functional teams from numerous specialties. I gained an in-depth clinical and product safety knowledge in addition to my radiological expertise, which includes all diagnostic and interventional modalities as well as teleradiology. My passion lies in pushing innovation and advancing current standard of care. I thrive in an environment where I can actively drive personalized, targeted medical solutions and innovative diagnostics through contributing not only my medical expertise, but also my project experience and analytical skills to cross-functional teams of experts - together seeking to transform patients’ lives.Particular interest in advancing personalized cancer treatment through research for new treatments and application of modern diagnostic tools.• ICH/GMP/GCP/GVP, ISO 13485• Health Canada, FDA and EMA guidelines• MS Office, MedDRA, Argus, PACS• Project Management and clinical research/pharmacovigilance training• All imaging modalities, Tumour response assessment, teleradiology• Adverse event & risk management• German/English fluent, intermediate French
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