Assistant Director, DMPK

Location: Carlsbad, California, United States

Salary: $153,848–$200,000 annually

Company

Ionis is a biotechnology company developing RNA-targeted medicines, gene-editing approaches, and therapies for serious diseases.

What you will do

• Develop and execute fit-for-purpose DMPK strategies for discovery, IND-enabling, and clinical-stage programs.
• Review DMPK studies covering protein binding, CYP and transporter interactions, hepatocyte stability, mass balance, excretion, QWBA, blood partitioning, and metabolite identification.
• Develop, optimize, qualify, and apply LC-MS/MS, UHPLC-HRMS, ligand-binding, and hybrid bioanalytical methods.
• Establish workflows for metabolite identification, profiling, semi-quantitation, and ultra-sensitive quantitation in biological matrices.
• Provide technical leadership for CRO selection, study execution, method transfer, data review, and report completion.
• Present scientific conclusions and recommendations to multidisciplinary teams, leadership, collaborators, and regulatory stakeholders.

Requirements

• Ph.D. in pharmaceutical sciences, analytical chemistry, biochemistry, pharmacology, or a related discipline, plus at least 5 years of relevant industry experience.
• Extensive experience developing, qualifying, and applying bioanalytical and DMPK methods.
• Hands-on expertise in LC-MS/MS, high-resolution mass spectrometry, metabolite identification and profiling, quantitative bioanalysis, and complex biological matrices.
• Experience with sample preparation methods including protein precipitation, liquid-liquid extraction, solid-phase extraction, immunocapture, and hybridization.
• Strong understanding of ADME principles, GLP requirements, and regulatory guidance for bioanalysis, DMPK, metabolite safety, and clinical development.
• Strong communication, organizational, data-integrity, collaboration, and technical leadership skills.

Nice to have

• Experience with oligonucleotide therapeutics, including ASOs, siRNAs, ligand-conjugated oligonucleotides, and peptide conjugates.
• Experience with Thermo Exploris, Q-Exactive, or comparable high-resolution mass spectrometry platforms and metabolite identification software.
• Experience with CYP inhibition and induction, drug transporter, and other DDI assays.
• Experience supporting IND, IB, CTD, NDA, or other regulatory submissions.
• Scientific leadership demonstrated through presentations, publications, cross-functional contributions, or external collaborations.

Culture & Benefits

• Onsite work environment focused on scientific excellence, innovation, and collaboration.
• Opportunity to contribute to therapies for patients with serious diseases and unmet medical needs.
• Excellent employee benefits package.
• Individual-contributor role with scientific leadership, collaboration, and technical mentorship responsibilities.