Senior Manager, Biomarker Operations

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.