About

Melissa Harney is the Head of Clinical Operations & Regulatory Affairs at HiFiBiO Therapeutics, where she leads global clinical execution and regulatory strategy across the company’s Immunology & Inflammation and Immuno-Oncology programs. She brings over 20 years of experience in clinical development, regulatory oversight, and global trial operations within the biotech and pharmaceutical sectors.

Prior to joining HiFiBiO, Melissa held senior clinical operations leadership roles at Seven and Eight Biopharmaceuticals and supported global development programs at Advaxis, Daiichi Sankyo, and Pearl Therapeutics (acquired by AstraZeneca). She has overseen clinical and regulatory activities supporting both in-licensing and out-licensing transactions, including programs advanced through strategic partnerships with Eikon Therapeutics and AstraZeneca.

Melissa holds a Bachelor of Science degree in Clinical Psychology and an Associate degree in Healthcare Science, and completed professional certification programs through Association of Clinical Research Professionals (ACRP).