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Job description
# Sr. Principal Scientist / DirectorFlagship Pioneering · Cambridge, MATailor My ResumeStart free. No credit card.### About the JobReporting to the Chief Scientific Officer, this role leads DMPK and bioanalytical strategy across nonclinical and clinical programs, operating as a hands-on scientific leader. We are looking for an accomplished DMPK and bioanalytical scientist with experience in PK study design, bioanalytical method development, and translational biomarker strategy. This person will support pharmacology and nonclinical toxicology programs, providing broader context across the nonclinical development portfolio. The ideal candidate brings deep scientific expertise and a hands-on approach and thrives in the fast-paced environment of a clinical-stage biotech where both scientific and strategic contributions are expected### 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* Manage and develop direct report(s); collaborate with the broader pharmacology team### Qualifications* 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
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Worksite address
cambridge, MA, 02140, US
Who can apply
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