Sr. Principal Scientist / Director, DMPK & Bioanalytical Sciences
Responsibilities
Lead DMPK and bioanalytical strategy across nonclinical and clinical programs, including PK, biomarker, and translational PD readouts
Lead method development, qualification, and validation for bioanalytical assays (GLP/GCP-compliant as required)
Design, execute, and oversee PK and PK-PD studies of tRNAs to evaluate delivery technologies (LNP and others) and biomarker effects
Manage and qualify CRO and external lab partners across bioanalytical and PK programs
Support nonclinical toxicology programs in collaboration with internal teams and CROs
Analyze, 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
Requirements
PhD or equivalent in pharmacokinetics, pharmacology, biochemistry, analytical chemistry, or related field
8+ years of industry experience in DMPK, bioanalytical sciences, or closely related function
Experience with a range of bioanalytical methods and their development, qualification, and validation in both nonclinical and clinical contexts (e.g. mass spectroscopy, ELISA, NGS, etc.)
Experience with ligand binding assays and multiplex immunoassay platforms (e.g., MSD, Luminex) for cytokine, immunogenicity, and biomarker analysis
Demonstrated CRO oversight - vendor qualification, study monitoring, data review
Experience designing and overseeing PK and PK-PD studies for novel delivery modalities; LNP experience preferred
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
Qualifications
Deep scientific expertise and a hands-on approach
Thrives in the fast-paced environment of a clinical-stage biotech where both scientific and strategic contributions are expected
Preferred Qualifications
Experience in rare disease, genetic medicine, or nucleic acid / RNA therapeutics
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 LC-MS/MS or related mass spectrometry platforms