Executive Director, Clinical Operations

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.