About this role
Responsibilities
- Lead and drive successful execution of the company’s clinical operation strategies through establishing consistent and deliverable operational plans across multiple cell therapy franchises.
- Establish study planning models, oversee efficient site start-up across multiple countries and drive patient recruitment as part of a unique outpatient administration and on-demand available cell therapy platform for broad patient access.
- Partner with executive team to plan and drive corporate clinical initiatives, and to establish delivery strategies, portfolio priorities, and progress metrics.
- Partner with larger clinical organization to provide operational input into clinical protocol design, study endpoints, enrollment strategy, and trial timelines.
- Provide strategic oversight of global cell therapy studies to deliver on timelines and cost allocations; own variable and headcount costs for the assigned portfolio, including forecasting, resource allocation assumptions, change order review, and cost containment, in partnership with Finance.
- Develop and oversee patient enrollment, data and timeline completion risk mitigation plans, patient data quality, and completion timelines.
- Maintain integration and alignment of Clinical Operations with key cross-functional departments including Clinical Outsourcing, Program Management, R&D, Manufacturing, Biometrics, Regulatory, QA, Safety/Pharmacovigilance, Legal, Finance, and external partners to translate portfolio strategy into executable plans; lead partnerships with external partners, vendors and CROs.
- Establish performance metrics, dashboards and forecasting models (enrollment, site activation, protocol deviations, query rates, cycle times) to drive accountability; oversee site selection, feasibility, activation, and engagement, including patient recruitment and retention.
- Build relationships with key opinion leaders, investigators, and sites to support innovation into clinical operations practice; travel to sites and represent the company at investigator meetings, advisory boards, conferences, and patient advocacy events; contribute to corporate planning, investor updates, and partnering or due diligence activities as needed.
- Lead development and continuous improvement of scalable SOPs, processes, and tools, ensuring adherence to GCP and applicable regulations.
- Build a culture of ownership, transparency, continuous improvement, and shape organizational design and hiring to match pipeline growth, balancing internal headcount with flexible resources.
Qualifications
- BS/BA or advanced degree with a minimum of 14 years of pharmaceutical and/or biotech experience in a clinical drug development setting.
- Strong leadership competencies and influencing skills with senior leaders and cross functional leaders.
- Extensive experience with clinical operations line management, performance management and staff coaching.
- Proven leadership of clinical operations functions and execution of clinical trials including successful study start-up, site selection, patient recruitment, and relationship building with investigators and CROs; Intimate knowledge of study site selection and site start up in the oncology or autoimmunity space.
- Experience in clinical resource allocation and budget forecasting.
- Management experience including outsourcing to third-party organizations, e.g., CROs.
- Expert knowledge of FDA and GCP regulations and guidelines.
- Experience in the development of protocols, SOPs, clinical study reports, INDs, NDAs and other clinical, regulatory and safety documents required.
- Effective oral and written communication skills to influence, inform and guide the clinical operational team.
- Strong project management skills.
- Proven teambuilding skills and ability to foster partnerships across projects and multidisciplinary teams.
- Experience in cell-based therapies is highly preferred.
- Excellent organizational, communication and people management skills required.
Working Conditions & Physical Requirements
- Travel may be required (up to 30%).
- 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 $280,000 - $300,000
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 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.
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