Biomarker Operations Leader for Clinical Trials

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

Benefits offered by this job

Annual bonus

Equity

Generous benefits package

Job summary

Fate Therapeutics is seeking a Senior Manager, Biomarker Operations to lead biomarker sample operations for clinical studies at our San Diego, CA headquarters. You will coordinate sample logistics, QA, and vendor relationships to ensure quality study execution and regulatory compliance.

You will collaborate with Translational and Clinical teams to design innovative collection and handling approaches, manage LIMS and data flows from CROs, and drive SOP updates across functions in a fast-paced,

Qualifications

• MS or higher in a relevant field with 3+ years in biomarker operations or BS with 5+ years of experience.
• Experience managing biomarker operations from study initiation through completion.
• Experience with clinical trial sites and CROs.

Responsibilities

• Lead day-to-day biomarker sample operations for clinical studies and manage sample logistics.
• Partner with Translational and Clinical teams to design biospecimen collection approaches.
• Maintain accurate sample inventories and oversee storage solutions.
• Collaborate with cross-functional stakeholders across functions.
• Support vendor qualification and audit activities with QA.
• Manage CROs and external labs to meet study specs.
• Coordinate meetings with internal and external stakeholders.
• Oversee contracts, MSAs, and related agreements for biomarker activities.
• Coordinate with Clinical and IT to manage data reporting from CROs.
• Provide cross-functional study updates on sample collection and assay status.
• Develop and update SOPs for cross-functional biomarker processes.

Skills

Biomarker ops

Project management

Cross-functional

CROs management

Vendor coordination

Communication

Education

MS or higher in relevant field

BS in life sciences

Tools

LIMS

IND filing familiarity

Job description

Fate Therapeutics is seeking a Senior Manager, Biomarker Operations to lead biomarker sample operations for clinical studies at our San Diego, CA headquarters. You will coordinate sample logistics, QA, and vendor relationships to ensure quality study execution and regulatory compliance.

You will collaborate with Translational and Clinical teams to design innovative collection and handling approaches, manage LIMS and data flows from CROs, and drive SOP updates across functions in a fast-paced,