Responsibilities. The Principal Investigator. manages regulated (e.g. GLP, GCP) and non-regulated PK, immunogenicity (ADA and NAb), and Biomarker studies. communicates the progress/study updates directly with sponsors via email and virtual meetings. Ensures the bioanalytical studies meet all the requirements of the study protocol, internal SOPs, and appropriate regulations. Collaborate with internal support/quality groups (QC, QA, etc) to ensure ...
