Executive Director, Clinical Operations

Fate Therapeutics, Inc.•San Diego, CA

11h•$280,000 - $300,000

About The Position

Fate Therapeutics is seeking an Executive Director, Clinical Operations to contribute to strategy and lead execution of global clinical operations across multiple cell therapy franchises. This senior leadership role drives the planning and delivery of studies using an off-the-shelf platform intended to broaden patient access. The position partners with the executive team, clinical leadership, and cross-functional colleagues to shape portfolio priorities and ensure operational excellence in site start-up, enrollment, and data quality, while owning timelines and budgets that advance the pipeline. The role provides strategic oversight of global cell therapy studies, builds high-performing teams and scalable processes, and leads clinical operations planning and execution. It includes responsibility for study delivery, operational metrics, resource allocation, budgets, risk mitigation, external partnerships, and continuous improvement while maintaining adherence to GCP and applicable regulations.

Requirements

BS/BA or advanced degree.
At least 14 years of pharmaceutical and/or biotech experience in a clinical drug development setting.
Strong leadership competencies and ability to influence senior and cross-functional leaders.
Extensive experience in clinical operations line management, performance management, and staff coaching.
Proven leadership of clinical operations functions and clinical trial execution, including 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 oncology or autoimmunity.
Experience in clinical resource allocation and budget forecasting.
Management experience that includes outsourcing to third-party organizations such as CROs.
Expert knowledge of FDA and GCP regulations and guidelines.
Experience developing protocols, SOPs, clinical study reports, INDs, NDAs, and other clinical, regulatory, and safety documents.
Effective oral and written communication skills to influence, inform, and guide the clinical operational team.
Strong project management skills.
Proven team-building skills and ability to foster partnerships across projects and multidisciplinary teams.
Excellent organizational, communication, and people management skills.
Ability to travel up to 30%.
Ability to tolerate extended periods of sitting and standing, vision to monitor, and moderate noise levels.

Nice To Haves

Experience in cell-based therapies is highly preferred.

Responsibilities

Lead execution of clinical operations strategies and establish consistent, deliverable operational plans across multiple cell therapy franchises.
Establish study planning models, oversee site start-up across multiple countries, and drive patient recruitment.
Partner with the executive team on corporate clinical initiatives, delivery strategies, portfolio priorities, and progress metrics.
Provide operational input into clinical protocol design, study endpoints, enrollment strategy, and trial timelines.
Oversee global cell therapy studies to deliver on timelines and cost allocations; own portfolio variable and headcount costs, including forecasting, resource allocation assumptions, change order review, and cost containment in partnership with Finance.
Develop and oversee risk mitigation plans for patient enrollment, data, and timeline completion, as well as patient data quality and completion timelines.
Coordinate Clinical Operations with internal cross-functional departments and external partners to turn portfolio strategy into executable plans; lead partnerships with external partners, vendors, and CROs.
Establish performance metrics, dashboards, and forecasting models for enrollment, site activation, protocol deviations, query rates, and cycle times.
Oversee site selection, feasibility, activation, and engagement, including patient recruitment and retention.
Build relationships with key opinion leaders, investigators, and sites; 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 the development and continuous improvement of scalable SOPs, processes, and tools, ensuring adherence to GCP and applicable regulations.
Build a culture of ownership, transparency, and continuous improvement, and shape organizational design and hiring to match pipeline growth while balancing internal headcount with flexible resources.