Helen Chalk
About Helen Chalk
Helen Chalk serves as the Vice President of Clinical Operations at Mythic Therapeutics, Inc., where she applies her extensive experience in clinical development and regulatory compliance. She has a strong background in leading clinical programs and has held various senior roles in prominent pharmaceutical companies.
Current Role at Mythic Therapeutics
Helen Chalk serves as the Vice President of Clinical Operations at Mythic Therapeutics, Inc. since 2023. In this role, she oversees clinical operations, ensuring that the company's clinical programs align with regulatory standards and industry best practices. Her leadership is crucial in advancing the company's mission to develop innovative therapies.
Previous Experience in Clinical Operations
Helen Chalk has held several significant positions in clinical operations prior to her current role. She worked as the Vice President of Clinical Operations at Mersana Therapeutics from 2020 to 2023. Before that, she was a Senior Director of Clinical Operations at TESARO, Inc. from 2016 to 2019, and a Senior Clinical Program Manager at Tolerx from 2006 to 2011. Her extensive background includes roles at Vertex Pharmaceuticals and PAREXEL, among others.
Educational Background
Helen Chalk earned her Bachelor of Science with Honors in Human Biology from Loughborough University, studying from 1990 to 1994. This educational foundation provided her with essential knowledge that supports her career in clinical operations and drug development.
Expertise in Clinical Trials and Regulations
Helen possesses expert knowledge of ICH/GCP guidelines and clinical trial regulations. This expertise is vital for ensuring compliance and maintaining quality across clinical operations. She has extensive experience in overseeing global clinical trials, including Phase 1-4 studies in various therapeutic areas such as oncology, infectious diseases, and autoimmune disorders.
Achievements in Drug Development
Helen Chalk has a proven track record in leading teams that have successfully filed Biologics License Applications (BLA), New Drug Applications (NDA), and Marketing Authorization Applications (MAA). Her contributions have significantly advanced drug development processes, particularly for therapies addressing unmet medical needs.