Senior Clinical Trial Manager

Fate Therapeutics is looking for a talented Clinical Operations professional to support our clinical studies. This position offers an excellent opportunity for a highly motivated individual to contribute to the successful coordination and execution of clinical studies with our iPSC platform. This role is expected to manage and oversee all study-level vendor and site related activities and issues related to one or more clinical trials. The successful candidate must have experience managing Phase I-III trials, driving enrollment, and a good knowledge of clinical operations, GCP, and the FDA regulatory environment. This is a full-time, exempt position located at our corporate headquarters in San Diego, CA.

• Lead all aspects of assigned clinical trials, guiding a cross-functional study team while promoting accountability, collaboration, and high performance.
• Manage all components of high complexity or elevated risk, global, and/or pivotal trials.
• Proactively manage CROs, vendors, and clinical sites to ensure timely deliverables and adherence to study plans.
• Apply critical thanking and data-driven decision-making to proactively identify risks, implement mitigation strategies, and resolve issues with speed and precision.
• Drive development and implementation of study documents, including protocol, monitoring plans, informed consent forms, and training materials.
• Ensure clinical trial activities are completed on time, within budget and in a highly dynamic and complex environment in accordance with appropriate quality standards including ICH/GCP requirements and Fate SOP.
• Lead the identification, evaluation, selection, and oversight of clinical trial sites.
• Partner efficiently, effectively, and professionally with assigned Clinical Research Associates (CRA) and participate in study sites to ensure effective study conduct.
• Author and implement operational plans to ensure efficient study enrollment and high-quality monitoring activities at clinical sites.
• Partner closely with Finance on study budget management, study budget forecast, vendor contracts and review/approve vendor and site invoices
• Responsible for the implementation and oversight of the Trial Master File (TMF), ensuring consistent, high-quality documentation to maintain inspection readiness at all times.
• Provide study updates and reports, inclusive of study risks and issues.
• Lead internal and external meetings for assigned clinical trial(s), including Investigator Meetings, conferences, iDMC, and study management meetings.
• Responsible for ongoing study data reviews and data cleaning activities. 
• Oversee Clinical Trial Associate and Clinical Research Associate activities such as site identification, qualification, selection, initiation, data quality, interim monitoring and close out activities.
• Manage trial-level quality risk management.
• Oversee study supplies management.
• Lead study training to investigators, site staff and internal staff on study processes.
• Participate in the preparation and follow up of internal process audits, vendor, and study site quality audits as well as regulatory inspections.
• Lead on-site/remote site booster visits.

• B.S. degree with a minimum of 7 years of experience managing clinical trials in biotech, pharmaceutical, and/or CRO environment.
• Oncology or autoimmune experience required.
• Immunotherapy or cellular therapy experience preferred.
• Strong working knowledge of clinical operations and experience with clinical study conduct from start-up through close-out.
• Global trials or CRO management experience preferred.
• Management experience of project teams along with the ability to lead cross functional study teams.
• Exceptional critical thinking, problem-solving, and communication skills.
• Proven ability to navigate ambiguity, prioritize tasks effectively, and make confident decisions in a fast-paced setting.
• Critical thinking and problem-solving skills—ability to anticipate challenges, analyze risks, and drive resolution
• Strong written and verbal communication with the ability to lead cross-functional teams effectively
• Proactive, accountable, and results-driven with a collaborative mindset
• Working knowledge of FDA/ICH guidelines and industry/technology standard practices including Good Clinical Practices; trial initiation and management practices and procedures.

• Onsite work at corporate headquarters in San Diego, CA.  
• Travel may be required.  
• Subject to extended periods of sitting and standing, vision to monitor, and moderate noise levels.

• 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 $175,000 - $195,000.

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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About Fate Therapeutics, Inc.

Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to bringing a first-in-class pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients with cancer and autoimmune diseases. Using its proprietary iPSC product platform, the Company has established a leadership position in creating multiplexed-engineered iPSC lines and in the manufacture and clinical development of off-the-shelf, iPSC-derived cell products. The Company’s effector cell pipeline includes multiplexed-engineered, iPSC-derived natural killer (NK) cell and T-cell product candidates, which incorporate novel synthetic controls of cell function, such as chimeric antigen receptors (CARs) to target tumor-associated antigens and are intended to deliver multiple mechanisms of therapeutic importance to patients including in combination with well-established cancer therapies. Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit www.fatetherapeutics.com.