Senior Director, Bioanalysis

Role: Senior Director of Bioanalysis providing strategic leadership for bioanalytical sciences across clinical and nonclinical programs, ensuring high-quality, regulatory-compliant data for PK/PD evaluations. Responsibilities: define and implement bioanalytical strategies, oversee external CRO partners, manage assay development/validation, and support regulatory submissions (IND/CTA, NDA/BLA); contribute to assay innovation and leadership in bioanalytical sciences; and serve as scientific liaison externally. Requirements: Ph.D. or advanced degree in analytical or pharmaceutical sciences; over 15 years of experience supporting clinical and nonclinical development; proven success managing CRO-based bioanalytical activities; expertise in LC-MS/MS, assay validation, and global regulatory standards (FDA, EMA, ICH M10, GLP/GCP). Preferred: experience with hybridization-based, ligand binding, and immunoassays; strong scientific judgment and cross-functional influence. High-Value: focus on modalities including small molecules, siRNA, and emerging platforms; role supports programs targeting metabolic disorders such as MASH, with ongoing Phase 3 trials. Work setup and travel details are not specified.