Clinical Operations Manager
CSBio is a peptide contract manufacturing founded in 1993. Our initial products were a complete line of automated synthesizers for manufacturing and process development, with a focus on cGMP production. In 1994, we opened our custom peptide facility and began producing high quality compounds for research organizations and pharmaceutical companies worldwide. In 2004, we opened our peptide production facility in Menlo Park, CA and in 2014, we expanded our production capability through the addition of a new, state of the art building dedicated to cGMP peptide production. In 2017, we passed a FDA inspection and were recommended to be approved for commercial drug substance manufacturing. In 2023, we added additional cGMP clinical production capacity in Milpitas, CA.
We seeking a hands-on Clinical Operations Manager to lead the planning and execution of longevity and oncology clinical programs. Reporting to the Chief Medical Officer, this person will translate clinical strategy and protocols into practical operating plans, lead study and site start-up, coordinate sites and vendors, manage timelines and budgets, and ensure consistent execution from feasibility through closeout. The Manager will support the build while preserving the medical, safety, regulatory, and investigator authority of qualified owners.
Job Duties:
- Lead clinical operations across longevity and oncology studies from feasibility and planning through study start-up, enrollment, conduct, c