Senior Scientist I, DMPK

Responsibilities

• Develop and implement in vitro and in vivo DMPK strategies to support preclinical development for compounds across multiple indications and routes of administration.
• Manage all DMPK activities, including oversight of internal resources and CRO partners to ensure high-quality and timely data delivery.
• Design, supervise, and execute preclinical PK studies, including non-compartmental analysis (NCA), data interpretation, reporting, and communication of PK/PD insights to project teams.
• 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).
• Contribute to a dynamic, fast-paced DMPK team by offering scientific leadership, troubleshooting support, and cross-functional collaboration.
• Maintain a current understanding of clinical pharmacology literature and regulatory guidance for oligonucleotide/RNAi therapeutics.

Requirements

• PhD in Pharmacometrics, Drug Metabolism, Pharmaceutical Sciences, or a related discipline with at least 3 years of industry experience.
• Deep and broad expertise in DMPK, 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, verbal, and written communication skills, with the ability to interpret and present complex scientific data clearly.