Principal Scientist
Core
Lead bioanalytical strategy and oversee bioanalytical activities for clinical programs, serving as the liaison between Bioanalytical Sciences and clinical study teams.
Role type
Principal Scientist (Bioanalytical Sciences Lead)
Builds
Bioanalytical deliverables including pharmacokinetics (PK), immunogenicity, and biomarker data for clinical studies.
Domain
Biopharmaceuticals / Clinical Bioanalysis
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Immunogenicity risk assessment, assay selection, sampling timepoint design, regulatory submission support, scientific document review, SOP compliance review, data presentation
Preferred skills
Experience with ELISA, ECL (MSD), LC-MS, PCR, flow cytometry, or immunogenicity assays
Technologies
ELISA, ECL (MSD), LC-MS, PCR, flow cytometry
Responsibilities
Manage bioanalytical strategy for clinical programs; Act as liaison between Bioanalytical Sciences and clinical development teams; Review sample analysis documentation and clinical sample analysis reports; Contribute to regulatory submissions and responses; Review clinical study-related documents including protocols and clinical study reports; Prepare and present scientific data at internal and external meetings
Seniority
Principal, strategy & mentorship
