Senior Manager, Biomarker Operations

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 looking for a Senior Manager, Biomarker Operations to help advance innovative clinical programs by shaping and executing biomarker sample strategies across studies. This is an exciting opportunity for a collaborative, detail-oriented operations professional who enjoys partnering across scientific, clinical, and vendor teams, solving complex challenges, and improving processes that support high-quality study execution. This is a full-time, exempt position located at our corporate headquarters in San Diego, CA.

Responsibilities

• Lead day-to-day biomarker sample operations for clinical studies, including sample logistics, issue resolution, protocol amendments, lab manual updates, study initiation materials, and escalation of study-related risks.
• Partner with Translational and Clinical teams to design and implement innovative, feasible biospecimen collection and handling approaches that uphold quality, ethical, and informed consent standards.
• Maintain accurate sample inventories and oversee short- and long-term sample storage solutions.
• Collaborate with cross-functional stakeholders, including Translational Scientists, Medical Monitors, Clinical Operations, Finance, Procurement, Legal, Data Management, and Quality Assurance.
• Work with Quality Assurance to support vendor qualification and audit activities.
• Manage CROs and external laboratories to ensure key deliverables, timelines, sample processing, testing, and data reporting meet study specifications and business requirements.
• Organize and facilitate meetings with internal and external stakeholders to support alignment and timely execution.
• Oversee central lab budgets, contracts, MSAs, legal agreements, and other agreements related to clinical biomarker activities, laboratories, and partnerships.
• Coordinate with Clinical and IT teams to manage data reporting from CROs into Fate and clinical study vendor systems, as appropriate.
• Provide cross-functional study updates to clinical study and biomarker teams, including sample collection, assay status, and analysis updates.
• Develop and update SOPs for cross-functional biomarker operational processes.

Qualifications

• MS or higher degree with 3+ years of experience in biomarker operations, or BS degree with 5+ years of relevant experience.
• Demonstrated experience managing clinical or biomarker operations from study initiation through completion, including collaboration with central labs and CROs to execute biomarker study plans.
• Experience working with clinical trial sites and related clinical CROs.
• Knowledge of cancer biology, immunology, biomarkers, drug development, and clinical trial methodology is a plus.
• Experience with one or more Laboratory Information Management Systems (LIMS) is strongly preferred.
• Prior experience or familiarity with IND preparation and filing is preferred.
• Strong planning, organization, and follow-through, with the ability to manage multiple high-priority projects and competing deadlines in a dynamic environment.
• Excellent interpersonal, verbal, written communication, presentation, and influencing skills.
• High emotional intelligence and a collaborative approach to working effectively across cross-functional teams.
• Innovative mindset with the ability to introduce new ideas, improve processes, and solve problems creatively.
• Flexibility in schedule and willingness to travel as needed.

Working Conditions & Physical Requirements

• Travel may be required (up to 10%).
• Subject to extended periods of sitting and standing, vision to monitor, and moderate noise levels.

Compensation

• The salary offer will be based on a variety of factors, including level, experience, qualifications, internal equity, and location.
• Fate offers a competitive employment package that includes an annual bonus, equity, and a generous benefits package.
• The anticipated salary range for this role is $150,000 - $165,000.

The preceding job description indicates the general nature and level of work performed by employees within this classification. Additional and incidental duties related to the primary duties may be required from time to time.

Equal Employment Opportunity

Fate Therapeutics, Inc. is an equal opportunity employer. We value diversity and are committed to creating an inclusive environment for all employees.

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AboutFate Therapeutics, Inc.

Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to bringing a pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients. Using its proprietary iPSC product platform, the Company has established a leadership position in creating multiplexed-engineered master iPSC lines and in the manufacture and clinical development of off-the-shelf, iPSC-derived cell products. The Company’s pipeline includes iPSC-derived T-cell and natural killer (NK) cell product candidates, which are selectively designed, incorporate novel synthetic controls of cell function, and are intended to deliver multiple therapeutic mechanisms to patients. Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit www.fatetherapeutics.com.