Sr. Principal Scientist / Director, DMPK & Bioanalytical Sciences

Role: Lead DMPK and bioanalytical strategy for nonclinical and clinical programs in a clinical-stage biotech, supporting pharmacology and toxicology efforts. Responsibilities: direct method development, qualification, and validation of bioanalytical assays (GLP/GCP-compliant); design and oversee PK, PK-PD, and biomarker studies, particularly with novel delivery modalities like LNPs; manage CRO and external laboratory partnerships; analyze and present DMPK and biomarker data; author regulatory documentation including IND sections; serve on leadership teams and collaborate cross-functionally; and develop team members. Requirements: PhD in pharmacokinetics, pharmacology, biochemistry, or analytical chemistry; 8+ years industry experience in DMPK/bioanalytical sciences; expertise in bioanalytical methods (mass spectrometry, ELISA, NGS), ligand binding, multiplex platforms (MSD, Luminex); CRO oversight experience; knowledge of PK/PK-PD studies in innovative delivery systems; biomarker assay development skills; strong scientific writing. Preferred: experience in rare/genetic diseases, nucleic acid/RNA therapeutics, LNP platform biology, GLP toxicology, LC-MS/MS platforms; leadership experience in a clinical-stage biotech. High-Value: focus on RNA therapeutics, translational biomarker strategy, PK/PD studies, CRO collaboration, and regulatory document authoring. WorkSetup: hands-on leadership in a fast-paced environment; reporting to CSO, with no specific location or travel details provided.