Clinical Biomarker & Diagnostic Lead
Core
Lead clinical biomarker and diagnostic strategies for oncology products in Japan to inform target engagement, mechanism of action, and patient selection.
Role type
Senior IC clinical biomarker and diagnostic lead
Builds
Clinical development plans, regulatory submissions, and high-quality biomarker data for oncology products
Domain
Oncology, Clinical Development, Japan regulatory landscape
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical biomarker strategy, diagnostic assay development, clinical trial design, regulatory affairs (Japan), data analysis, external lab management, GCP principles
Preferred skills
IHC and NGS assays, bioinformatic analysis, reimbursement strategy, scientific publications
Technologies
IHC, NGS, bioinformatics tools
Responsibilities
Lead biomarker and diagnostic strategies for early- and late-stage oncology programs; oversee implementation of biomarker assays and testing strategies; provide scientific input to clinical protocols and lab manuals; manage interactions with external laboratories and vendors; communicate biomarker insights to cross-functional stakeholders
Seniority
Senior, hands-on IC
