About this role
Role Overview
- Define and drive the biomarker operations strategy
- Manage and develop a team of manager‑level direct reports
- Lead vendor strategy and performance management
- Provide budget and resource stewardship
- Develop knowledge assets (playbooks, SOPs, training)
- Drive process improvement and operational scale‑up
- Establish role clarity and ways of working across teams
- Partner closely with Clinical Operations, Regulatory, Quality, Data Management, and external labs
- Own operational delivery for multiple biomarker programs
- Oversee sample lifecycle management and lead escalation/mitigation for issues
Requirements
- 8 -10+ years in biomarker/clinical operations (biopharma/biotech/CRO) covering global studies
- Extensive experience designing, implementing, and scaling standardized workflows
- Proven experience leading operational aspects of biomarker programs
- Deep knowledge of immunoassay platforms (e.g., flow cytometry, IHC, proteomics, NGS)
- Strong working knowledge of FDA/EMA expectations for biomarker assays
- Track record qualifying/overseeing CROs and specialty labs performance management
Benefits
- Health insurance
- Professional development opportunities