Senior Specialist, Biomarker
Core
Lead operational oversight of clinical trial laboratory vendors and specialty labs, supporting biomarker strategy, assay feasibility, and regulatory submissions.
Role type
Senior Specialist, Biomarker (Clinical Operations & Strategy)
Builds
Clinical trial data, regulatory submissions, scientific reports, and biomarker strategy outputs
Domain
Biotechnology / Clinical Development / Biomarker Discovery
Required skills
Vendor management, sample logistics, assay feasibility assessment, scientific literature review, data analysis, regulatory documentation, SOP development
Preferred skills
Knowledge of FDA/EMA expectations, statistical concepts, cross-functional collaboration
Technologies
None explicitly stated
Responsibilities
Lead operational oversight of clinical trial laboratory vendors and specialty labs; Coordinate biomarker vendors, CROs, and external experts; Support biomarker strategy and assay feasibility assessment; Identify and evaluate emerging or novel biomarker candidates; Perform literature reviews and prepare scientific summaries and decision-support materials; Support data analysis, interpretation, and figure preparation; Collect and organize biomarker data for regulatory submissions
Seniority
Senior, hands-on IC