Biomarker Operations Lead for Clinical Trials

Fate Therapeutics; San Diego (CA); On-site; USD 150,000 - 165,000; Full time

Benefits offered by this job

Annual bonus

Equity

Benefits package

Job summary

Fate Therapeutics is seeking a Senior Manager, Biomarker Operations to lead day-to-day biomarker sample activities across clinical studies. You will partner with Translational and Clinical teams to implement innovative collection and handling approaches while maintaining quality and consent standards.

You will manage sample inventories, data flow from CROs, and external labs, ensuring timely delivery and compliance. Travel up to 10% may be required.

Qualifications

• MS or higher degree with 3+ years of biomarker operations experience or BS with 5+ years of relevant biomarker ops experience.
• Experience managing clinical or biomarker operations from study initiation through completion, including collaboration with central labs and CROs.
• Familiarity with clinical trial sites and related clinical CROs.
• Knowledge of cancer biology, immunology, biomarkers, drug development, and trial methodology is a plus.
• Experience with LIMS is strongly preferred.
• IND preparation and filing familiarity is a plus.

Responsibilities

• Lead day-to-day biomarker sample operations for clinical studies, including sample logistics and risk escalation.
• Collaborate with Translational and Clinical teams to design feasible biospecimen collection and handling approaches.
• Maintain accurate sample inventories and oversee storage solutions.
• Coordinate with cross-functional stakeholders to ensure timely study execution.
• Support vendor qualification and audit activities with Quality Assurance.
• Manage CROs and external labs to meet study specs and timelines.
• Organize meetings with internal and external stakeholders for alignment.
• Oversee budgets, contracts, MSAs, and related agreements.

Skills

Biomarker operations

Cross-functional collaboration

Project management

Communication

Problem solving

Education

MS or higher in a related field

BS in a related field with 5+ years experience

Tools

LIMS

CRO/vendor management

Job description

Fate Therapeutics is seeking a Senior Manager, Biomarker Operations to lead day-to-day biomarker sample activities across clinical studies. You will partner with Translational and Clinical teams to implement innovative collection and handling approaches while maintaining quality and consent standards.

You will manage sample inventories, data flow from CROs, and external labs, ensuring timely delivery and compliance. Travel up to 10% may be required.