Senior Scientist, Translational Science

About the role

Supports outsourced bioanalytical and biomarker work for clinical programs, focusing on pharmacokinetic, immunogenicity and pharmacodynamic assays run at contract research organisations.

What you will do

• Oversee daily outsourced bioanalytical work for pharmacokinetic, immunogenicity and biomarker assays at contract labs
• Give scientific input on method design, development, qualification, validation and upkeep
• Review protocols, validation plans, analysis plans and data packages for quality and integrity
• Track milestones with labs and internal partners, flag risks and secure quotes, contracts, samples and reagents
• Coordinate clinical sample testing across studies, including priorities, lab timelines and data delivery
• Investigate assay and sample analysis problems with internal and external experts and summarise findings

What they look for

• PhD in biology, biochemistry, pharmacology, chemistry or similar with 2 or more years of industry experience, or MS with 5 or more years in
• Experience with large-molecule pharmacokinetic and immunogenicity assays, including neutralising antibody methods
• Experience overseeing contract research organisations, including review of technical documents, data and reports
• Knowledge of GLP, GCLP, data integrity principles and bioanalytical regulatory expectations
• Experience writing or reviewing bioanalytical reports and contributing to regulatory submissions