How to Apply
Please click the link at the bottom of the posting to submit an application.
The Associate Director / Director, Clinical Scientist will collaborate with cross-functional teams (Clinical, Regulatory, Medical Writing, Translational Sciences, CMC, etc.) on writing clinical study synopses and protocols, Investigator Brochures, and clinical study reports; participating in emerging clinical trial data evaluation and interpretation; ensuring that assigned studies are conducted according to GCPs and Cabaletta’s SOPs; interacting with health authorities such as the FDA related to clinical trials, reviewing SAPs and TLF shells; conducting literature searches; overseeing the review of clinical study entries (clinical trial information and results) for posting to www.clinicaltrials.gov (clinical trial registry and results database) and assisting in preparation of IND/ BLA filing and accelerated/pediatric programs packages. The span of responsibilities is broad and will support several clinical programs depending on their size and complexity. The Clinical Scientist will liaise with various vendors and study investigators at participating sites.