Cambridge, England, United Kingdom
Responsible for devising the biomarker strategy for assigned projects across their development lifecycle i.e. from pre-clinical phase to clinical proof of concept, and potentially through to late development/market. Provide scientific leadership in preclinical and clinical translational research programs within the immuno-oncology space in close collaboration with research/biology. Identify, develop, and implement clinical biomarker strategy for early clinical programs, including supporting the determination proof of mechanism, informing and supporting dosing regimen, defining pharmacodynamic markers and indication selection in close collaboration with research/biology. Collaborate with internal labs as well with contract research organisations on all the aspects of the biomarker analytics, including method development, method transfer, fit-for -purpose validation and oversight of clinical study measurements. Work as a member of the clinical study team as subject matter expert for executing clinical study setup & conduct, contributing to the study protocol development and review, preparing submissions, addressing regulatory queries, developing and implementing bioanalytical strategies & assays, and delivering regulatory compliant data and reports within program timelines.