Principal / Senior Principal Scientist, DMPK
$179,000 - $236,000
Apply (opens in a new tab)Principal / Senior Principal Scientist, DMPK
Posted today
SENIORITY
Manager
SALARY
$179,000 - $236,000
About the role
- Lead DMPK strategy and oversee bioanalytical work across nonclinical and clinical programs, including PK, biomarker, and translational PD readouts
- Oversee development, qualification, and validation of nonclinical and clinical bioanalytical assays (GLP/GCP-compliant as required), as well as sample analysis, working with internal and CRO analytical scientists
- Design, execute, and oversee PK and PK-PD studies of tRNAs to evaluate delivery technologies (LNP and others), biodistribution, and biomarker effects
- Lead PK and PK-PD data analysis and interpretation across mouse, rat, NHP, and human studies to support dose selection
- Manage and qualify CRO and external lab partners across bioanalytical and PK programs
- Support nonclinical toxicology programs in collaboration with internal teams and CROsAnalyze, interpret, and present DMPK and translational biomarker data to internal leadership and external stakeholders
- Author nonclinical sections of regulatory filings (e.g., IND) and briefing documents; support agency interactions and responses
- Serve on the Research Leadership Team; represent DMPK and bioanalytical sciences in cross-functional program discussions
- Manage and develop direct report(s); collaborate with the broader pharmacology team
- PhD or equivalent in pharmacokinetics, pharmacology, biochemistry, or related field 8+ years of industry experience in DMPK or a closely related function
- Working knowledge of bioanalytical methods (e.g., LC-MS/MS, ligand binding assays, NGS) sufficient to oversee their development, qualification, and validation and the associated sample analysis in nonclinical and clinical contexts
- Demonstrated CRO oversight - vendor qualification, study monitoring, data review
- Experience designing and overseeing in vivo nonclinical PK and PK-PD studies for novel delivery modalities; LNP experience preferred
- Hands-on experience with PK and PK-PD data analysis (e.g., noncompartmental analysis) and associated software (e.g., Phoenix WinNonlin), applied to the design and interpretation of nonclinical and clinical studies
- Experience in translational or clinical biomarker development, including assay strategy and fit-for-purpose qualification
- Strong scientific writing skills - regulatory documents (e.g., IND nonclinical sections) and internal study reports
- Experience supervising and developing scientists
- Experience in rare disease or genetic medicine
- Experience with RNA-based therapies
- Familiarity with LNP platform biology and delivery landscape
- Familiarity with GLP toxicology study design and ICH nonclinical guidelines
- Experience operating in a cross-functional leadership role at a clinical-stage biotech
- Experience with ligand binding assays and multiplex immunoassay platforms (e.g., MSD, Luminex) for cytokine, immunogenicity, and biomarker analysis
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