Director, Pharmacokinetics & Bioanalysis

Seeking an experienced Bioanalytical Development leader to oversee PK assay development and validation for oligonucleotide therapeutics. This role will support both clinical and nonclinical studies, drive assay lifecycle management, and collaborate cross-functionally with QCP, Clinical, and Translational teams.Key Responsibilities:Lead development and validation of PK and ligand-binding assays (LC-MS/MS, ELISA, qPCR)Manage CROs and ensure high-quality, regulatory-compliant dataSupport IND/NDA filings and ensure compliance with GLP/GCP and ICH guidelinesAnalyze and interpret PK, ADME, and immunogenicity dataKey Requirements:Ph.D. with 7+ years in bioanalytical development (biotech/pharma)Strong expertise in oligonucleotide therapeutics (siRNA, ASOs)Experience with complex biological matrices and assay validationProven leadership, CRO management, and cross-functional collaboration skills