The Clinical Trial Manager (CTM) is a key member of Clinical Operations and will closely partner with the Associate Director, Clinical Program Management. Assist Clinical Program Manager with set-up of regional CRO and other vendors as required, including liaising with Global CRO to ensure site training and timely initiation. May serve as the key operational contact for Akero studies aiding in site selection, study implementation and ongoing coordination of study sites, either directly or via CROs.
Reporting to the Associate Director, Formulation Sciences, the Senior Manager, Formulation Sciences will follow programs through the development stages and play a pivotal role as a drug product subject matter expert in supporting all matters relating to drug product development and manufacturing; the Senior Manager will lead technical transfers, oversee drug product process development and manufacturing, and design DOEs to proof a process design space.
This team-player role is responsible for supporting aspects of clinical operations for our programs. You will work with peers and stakeholders across multiple disciplines to drive a key program with multiple studies and indications through all phases of clinical trials (Phase I-III). You'll provide support and experience to the program and members of our Clinical Development team to ensure the seamless execution of clinical trials.