Sharon Mc Bain
About Sharon Mc Bain
Sharon Mc Bain serves as the Vice President and Head of Regulatory at Geron Corporation, a position she has held since 2019. With over 20 years of experience in regulatory affairs, she has a strong background in oncology and myeloid malignancies, having previously worked at notable companies such as Johnson & Johnson and GlaxoSmithKline.
Work at Geron
Sharon Mc Bain has served as Vice President, Head of Regulatory at Geron Corporation since 2019. In this role, she oversees regulatory strategies and ensures compliance with global regulatory requirements. Her leadership contributes to the advancement of Geron’s projects, particularly in the field of oncology. Mc Bain's extensive experience in regulatory affairs supports the company's mission to develop innovative therapies.
Previous Experience at Johnson & Johnson
Before joining Geron, Sharon Mc Bain held significant positions at Johnson & Johnson. From 2015 to 2019, she was the Senior Director, Global Regulatory Lead for Oncology, where she managed regulatory strategies for oncology products. Prior to that, from 2014 to 2018, she served as Senior Director, Global Regulatory Lead for Immunology. Her roles involved overseeing regulatory submissions and ensuring compliance in the UK.
Background in Regulatory Affairs
Sharon Mc Bain has over 20 years of experience in regulatory affairs. Her career includes roles at notable pharmaceutical companies such as GlaxoSmithKline and Biogen Idec. At GlaxoSmithKline, she served as Head of GI/Metabolic and later as Director of Regulatory Affairs. Her background includes a strong focus on global regulatory procedures and strategic project management, particularly in myeloid malignancies.
Education and Expertise
Sharon Mc Bain earned a BSc in Applied Biology with First Class honors from the University of London, studying from 1979 to 1981. Her educational background laid the foundation for her extensive career in regulatory affairs. Mc Bain specializes in myeloid malignancies and has led initiatives to establish critical endpoints in clinical trials, demonstrating her expertise in the regulatory landscape.
Achievements in Regulatory Initiatives
Sharon Mc Bain has made significant contributions to regulatory initiatives throughout her career. Notably, she led the effort at Janssen to establish minimal residual disease as a surrogate endpoint for overall survival in acute myeloid leukemia (AML). Additionally, she represented Janssen at an FDA-sponsored open public meeting, participating in discussions that influence regulatory policies in oncology.