Senior Scientist, Clinical Research – Biomarker Operations

Responsibilities

• Planning and executing clinical-trial biomarkers across the pipeline
• Ensuring compliant, efficient biospecimen collection, assay execution, and data delivery
• Driving operational excellence, data quality, and compliance across the biomarker assay project lifecycle
• Partnering closely with scientific and operational colleagues to support a cohesive and agile team that delivers high-quality biomarker data for clinical trials and translational research
• Collaborating closely with biomarker scientists and study teams to plan clinical-trial biomarker set‑up and logistics
• Serving as the operational partner to Biomarker Leads, helping implement strategies that advance biomarker programs
• Co‑authoring biomarker‑related sections of clinical study protocols
• Collaborating with Translational Molecular Biomarker Scientists to define and manage specimen collection, handling, shipping, storage, and processing requirements
• Developing biomarker vendor statements of work and data‑transfer specifications in partnership with clinical teams
• Working with clinical teams to coordinate sample and assay logistics, issue resolution and risk mitigation
• Partnering with Data Management to transfer biomarker data from external vendors into the clinical data repository
• Designing sample collection kits, laboratory manuals, and specimen logistics for shipments to third‑party vendors
• Building and maintaining effective partnerships with external biomarker vendors and internal teams
• Proactively identifying and resolving conflicting stakeholder needs to maintain alignment and momentum
• Implementing and continuously improving streamlined workflows that maximize efficiency and data quality

• Bachelor’s (with 5+ years) or Master’s or higher (with 3+ years) in a scientific or technological field of study and relevant experience
• Project management experience
• Experience in drug discovery and/or clinical research
• Ability to excel in fast‑paced, evolving conditions and advocate for operational excellence
• Excellent written and verbal communication skills, with the ability to work within a highly collaborative, matrixed environment