Senior Scientist I, DMPK

Responsibilities:
- Develop and implement in vitro and in vivo DMPK strategies to support preclinical development across multiple indications and routes of administration.
- Manage all DMPK activities, including oversight of internal resources and CRO partners to ensure high-quality, timely data delivery.
- Design, supervise, and execute preclinical PK studies, including non-compartmental analysis (NCA), data interpretation, reporting, and communication of PK/PD insights.
- Prepare and deliver IND-enabling DMPK packages, ensuring compliance with regulatory expectations and contributing to regulatory submissions.
- Apply working knowledge of GLP/GCP principles and ensure appropriate documentation for regulated studies.
- Support GLP toxicokinetic (TK) study design, analysis, and reporting.
- Oversee metabolite identification in preclinical and clinical samples using high-resolution mass spectrometry (HRMS).
- Provide scientific leadership, troubleshooting support, and cross-functional collaboration within the DMPK team.
- Maintain current understanding of clinical pharmacology literature and regulatory guidance for oligonucleotide/RNAi therapeutics.

Requirements:
- PhD in Pharmacometrics, Drug Metabolism, Pharmaceutical Sciences, or related field; at least 3 years of industry experience.
- Deep and broad DMPK expertise, with working knowledge of nucleotide or oligonucleotide drug metabolism and distribution (highly desired).
- Hands-on experience with in vitro ADME assays, in vivo PK studies, drug–drug interaction (DDI) evaluations, and Phoenix WinNonlin.
- Experience with LC–MS/MS and HRMS, ideally applied to oligonucleotide therapeutics.
- Strong background in organic chemistry, biochemistry, and drug biotransformation.
- Demonstrated experience in drug development and understanding of regulatory processes.
- Excellent interpersonal and communication skills; ability to interpret and present complex scientific data clearly.