Mihaela (Mani) Nistor has a diverse background in pharmaceutical sciences, nursing, biomedical research and human research protections. She brings over two decades of expertise in regulatory oversight, clinical trial management and process optimization. Mani's leadership pedigree is strengthened by advanced training, including a High-Performance Leadership Certificate from Cornell and Lean Six Sigma Yellow Belt, reflecting a commitment to operational excellence and to improving company functions. 

Prior to joining Immunis, Mani was a Clinical Research Manager at UC Irvine, where she oversaw regulatory activities and managed high-priority cell and gene therapy clinical trials in accordance with strict federal and state regulations. Having led regulatory start-up and management for numerous clinical studies, Mani has demonstrated a proven talent for developing efficient regulatory processes, training clinical teams and ensuring the highest standards of compliance. Her experience encompasses overseeing IRB review operations, spearheading human embryonic stem cell research oversight and facilitating successful site monitoring and sponsor interactions across a range of advanced biomedical initiatives. 

Mani holds a PharmD from the University of Medicine and Pharmacy in Targu-Mures, Romania, and a Registered Nurse credential, complemented by extensive certifications in research administration, diversity development, mediation and management. Her reputation as a mentor and innovator is evident in her ability to train and promote staff, refine research documentation and lead teams through complex regulatory challenges.