Description
Reporting to the Chief Scientific Officer, this role leads DMPK strategy and oversees bioanalytical work across nonclinical and clinical programs, operating as a hands-on scientific leader.
We are looking for an accomplished DMPK scientist with experience in PK and PK-PD study design, PK data analysis and interpretation, and translational biomarker strategy.
Responsibilities:
- 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, 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, 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 CROs
- Analyze, interpret, and present DMPK and translational biomarker data to internal leadership and external stakeholders
- Author nonclinical sections of regulatory filings 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
Required Qualifications:
- 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, such as LC-MS/MS, ligand binding assays, and NGS
- Demonstrated CRO oversight, including vendor qualification, study monitoring, and 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 and associated software, such as Phoenix WinNonlin
- Experience in translational or clinical biomarker development, including assay strategy and fit-for-purpose qualification
- Strong scientific writing skills, including regulatory documents and internal study reports
- Experience supervising and developing scientists
Preferred Qualifications:
- 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 for cytokine, immunogenicity, and biomarker analysis