Associate Director, Biology

Role: Associate Director, Biology overseeing GLP-regulated bioanalytical activities to support nonclinical and clinical studies in a biotech setting. Objectives include ensuring assay development/validation for PK, TK, PD, supporting regulatory submissions, and identifying biomarkers for pharmacodynamics. Responsibilities encompass managing bioanalytical assay operations, collaborating with pharmacology and CMC teams on biomarker and assay development, managing CROs and vendors, and contributing to regulatory documentation. Required qualifications: 15+ years in biopharma with 10+ years in regulated bioanalysis, extensive experience managing GLP-compliant CROs, and supporting regulatory submissions; bachelor’s degree in biology or relevant sciences. Preferred skills include familiarity with nonclinical and clinical pharmacology data interpretation, GxP standards, and assay validation. High-value specifics involve expertise supporting biotech programs in early to mid-stage development, with focus on small molecule or biologic therapies, within GLP, GCP, and regulatory environments (FDA, EMA). Collaboration primarily with nonclinical, clinical, regulatory, and CMC teams. Location/work setup not specified; focus on senior-level expertise and regulatory compliance.