Angitia Biopharmaceuticals

Director

• Serve as BABM expert on cross-functional drug development teams and lead BABM related program(s) and activities
• Lead internal process and procedure setup and develop corresponding SOPs
• Lead and manage BABM data interpretation, and reporting; present bioanalytical results and update BA status to study teams
• Interface with internal study and clinical teams to define and execute BABM strategies
• Write and review relevant sections of study protocols, analysis plans (assay development and validation plans, sample analysis plan), reports (validation report, sample analysis report), Investigator Brochures, documents for IND filings and NDA/BLA submissions
• Select and manage BABM CROs conducting regulated (e.g. GLP, GCP) and non-regulated PK, immunogenicity (ADA and NAb), and Biomarker sample analysis
• Monitor BABM CROs process and procedures to ensure their work qualities

Senior Manager / Associate Director, Bioanalytical and Biomarker Sciences