Description
BridgeBio is hiring an experienced TMF Operations Lead to establish and lead the Trial Master File strategy across the BBP-418 clinical development program. The role oversees TMF completeness, accuracy, governance, inspection readiness, CRO performance, quality reviews, audit support, CAPA, and cross-functional TMF processes while serving as the TMF subject matter expert. Candidates need a university degree or comparable professional education, preferably in a relevant field, or more than eight years of experience in similar roles; the role requires 8+ years of TMF Operations, Clinical Operations, or Clinical Quality experience, strong knowledge of ICH-GCP and ALCOA+, and proficiency with Microsoft Office, Smartsheet, and SharePoint. The position offers a California salary range of $191,000–$220,000 USD, hybrid work, and comprehensive health benefits.
