The posting
Fate Therapeutics is seeking a Clinical Trial Manager or Senior Clinical Trial Manager to lead complex clinical studies from start-up through close-out, ensuring high-quality execution, strong site and vendor partnerships, and timely delivery of key milestones. This role is ideal for a highly organized and proactive clinical operations leader who is motivated to advance innovative therapies in oncology and/or autoimmune disease. The successful candidate will bring hands-on clinical operations experience, sound judgment, and the ability to lead cross-functional teams, solve problems proactively, and communicate clearly in a fast-paced environment. This is a full-time, exempt position located at our corporate headquarters in San Diego, CA.
Responsibilities
- Independently lead complex or high-risk clinical trials from start-up through close-out, including study team leadership, timelines, enrollment strategy recommendations, risk mitigation, and completion planning.
- Ensure study deliverables are completed on time, within budget, and in compliance with GCP/ICH requirements, company SOPs, and applicable quality standards.
- Manage study budgets, forecasts, projections, invoice review and approval, and vendor spend in partnership with Finance and Clinical Operations.
- Lead site identification, evaluation, qualification, initiation, monitoring, booster visits, and close-out; partner with investigators, site staff, and field personnel to support study conduct and timely data collection.
- Develop and oversee enrollment strategies, monitoring plans, source document verification, data review, cleaning, freeze readiness, and data quality activities.
- Manage clinical vendors, including RFI/RFP support, vendor evaluation, selection, oversight, issue resolution, and performance management.
- Oversee Trial Master File implementation and maintenance to ensure ongoing inspection readiness.
- Drive development, review, and approval of study documents and tools, including protocols, informed consent forms, budgets, monitoring reports, project plans, logs, templates, newsletters, and operational materials.
- Provide concise study updates, reports, risks, and issues to senior management; escalate concerns promptly with recommended solutions.
- Provide oversight, training, mentoring, delegation, and dotted-line management, as applicable, for CTMs, CTAs, CRAs, and assigned clinical trial staff.
- Develop and deliver study training for investigators, site staff, and internal teams; support study supplies management and related operational processes.
- Support internal process, vendor, and site quality audits and regulatory inspections, including preparation, participation, and follow-up.
- Lead or participate in internal and external study meetings, Investigator Meetings, iDMC meetings, conferences, and events.
- Develop SOPs, best practices, and process improvements to strengthen clinical trial execution.
Qualifications
- B.S. degree with at least 6 years of clinical trial management experience in a biotech, pharmaceutical, and/or CRO environment.
- Strong clinical operations expertise, including end-to-end study conduct from start-up through close-out, global trial execution, and CRO/vendor management.
- Highly organized and self-directed, with the ability to manage multiple priorities, meet deadlines, and work with minimal supervision.
- Oncology, autoimmune, or cell therapy experience highly preferred.
- Working knowledge of FDA/ICH guidelines, Good Clinical Practice, clinical trial initiation and management practices, and pharmaceutical and clinical development processes.
- Demonstrated leadership, decision-making, problem-solving, and cross-functional study team management skills.
- Ability to engage, influence, and collaborate effectively across matrixed organizations and with external partners, including investigators, clinical sites, and vendors.
- Excellent communication skills and professional demeanor; able to work effectively with medical personnel, clinical monitors, statisticians, data managers, medical writers, and internal cross-functional partners.
Working Conditions & Physical Requirements
- Travel required, including periodic site visits and conferences to ensure the integrity of the study.
- 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 $135,000 - $180,000.
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.
Privacy Notice
To learn about how Fate collects and uses job application information, please visit Fate's online Privacy Notice.
About Fate 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.
⚠️ Recruitment Fraud Alert
Recently, we have been made aware of unauthorized individuals falsely presenting themselves as Fate Therapeutics employees or recruiters as part of online scams or phishing attempts. Impersonators may use the Fate Therapeutics name and logo, as well as employee names and job titles, to gain a job seeker’s personal or banking information or to request payment as a condition of being considered for a position at the company. Fate Therapeutics and its employees are not involved in these scams.
Here are a few things to be aware of to help identify recruitment fraud:
- Our Talent Acquisition team only corresponds from our @fatetherapeutics.com domain.
- At no stage in our hiring process will we require payment or ask you to make deposits in your bank account.
- We will only ask for personal information when applying for a position via our Careers page or thereafter.
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- We do not use Google Hangouts, WhatsApp, or other third-party messaging platforms to recruit candidates or conduct interviews.
Please exercise caution. If something feels off about your interactions, we encourage you to contact us at [email protected] to confirm the authenticity of the message. Your security is important to us, and we appreciate your vigilance.
