Maria C. Yonchek, Bsn, Rn
About Maria C. Yonchek, Bsn, Rn
Maria C. Yonchek, BSN, RN, serves as the Senior Director of Clinical Operations at Asklepios BioPharmaceutical, Inc. She has extensive experience in clinical drug development and regulatory compliance across various therapeutic areas.
Current Role at Asklepios BioPharmaceutical
Maria C. Yonchek serves as the Senior Director of Clinical Operations at Asklepios BioPharmaceutical, Inc. (AskBio) since 2022. In this role, she oversees clinical operations and contributes to the strategic direction of clinical drug development. Her position is based in Greater Philadelphia, with a remote work arrangement. She applies her extensive experience in managing cross-functional project teams to facilitate the drug development process.
Previous Experience in Clinical Operations
Maria has held several key positions in clinical operations prior to her current role. She worked at Castle Creek Biosciences, Inc. as Director of Clinical Operations from 2019 to 2022. Before that, she served as Director of Clinical Operations at Dermavant Sciences for 11 months in 2018-2019. Additionally, she was the Associate Director of Global Clinical Operations at Auxilium Pharmaceuticals from 2012 to 2013. Her diverse experience spans various therapeutic areas, including dermatology and oncology.
Educational Background in Nursing
Maria C. Yonchek earned her Bachelor of Science in Nursing (BSN) from Neumann University. Her educational background in nursing provides her with a solid foundation for her work in clinical operations and drug development. This training enhances her understanding of patient care and clinical practices, which is essential in her role in the pharmaceutical industry.
Expertise in Regulatory Compliance
Maria possesses expertise in regulatory compliance, particularly in Good Clinical Practice (GCP) and Good Laboratory Practice (GLP). Her knowledge in these areas ensures that clinical trials adhere to regulatory standards, which is critical for the successful development and approval of new drugs. This expertise is complemented by her experience in managing the drug development process from IND submissions to NDA/MAA filings.
Skills in Clinical Drug Development
Maria has hands-on management skills that facilitate clinical drug development. She is experienced in conducting first-in-man studies, particularly in oncology, and has a broad understanding of critical path dependencies in drug development activities. Her ability to build stakeholder confidence and provide transparency in communicating corporate goals is vital for the success of clinical projects.