Katherine Dale
About Katherine Dale
Katherine Dale is an Executive Director and Head of Medical Writing at Arcus Biosciences, with extensive experience in small molecule and biologics development. She has held significant roles in various organizations, including AbbVie and HUTCHMED, and has authored numerous regulatory documents across multiple therapeutic areas.
Work at Arcus Biosciences
Katherine Dale serves as the Executive Director and Head of Medical Writing at Arcus Biosciences. She has been in this role since 2023, contributing her extensive expertise in medical writing to support the company's development programs. Her responsibilities include overseeing the medical writing team and ensuring the quality and compliance of regulatory documents.
Previous Experience in Medical Writing
Katherine Dale has held several significant positions in the field of medical writing prior to her current role. She worked at HUTCHMED as the Head of Medical Writing from 2021 to 2023. Before that, she was the Sr. Vice President of Global Medical Writing and Transparency at Treximo from 2019 to 2021. Her experience also includes roles at AbbVie, Global Medical Writing & Translation, Kendle International, and Worldwide Clinical Trials.
Education and Expertise
Katherine Dale earned her Bachelor's degree from the University of Kentucky, where she studied from 1990 to 1994. She later obtained a Master's degree from the University of Louisville between 1995 and 1997. Additionally, she holds a Russian Language Certificate from the National Mineral Resources University, which she completed in 1994. Her educational background supports her extensive knowledge in medical writing and regulatory submissions.
Achievements in Regulatory Submissions
Katherine Dale has been a pivotal member of several New Drug Application (NDA) submission teams, notably serving as the Oncology Lead Submission writer at AbbVie. She has authored over 60 clinical study reports, protocols, safety summaries, and other regulatory documents. Her experience includes managing the outsourcing strategy for the neuroscience portfolio at Eli Lilly, showcasing her leadership in regulatory writing.
Therapeutic Areas Experience
Katherine Dale possesses a broad range of experience across various therapeutic areas. Her expertise includes cardiovascular, endocrine, oncology, neuroscience, immunology, respiratory, infectious diseases, and rare and orphan diseases. This diverse background enables her to contribute effectively to medical writing projects across different domains.