Director, Clinical Operations

Director, Clinical Trial Operations

South San Francisco, CA | Hybrid

About Our Client

Our client is a clinical-stage biotechnology company focused on advancing allogeneic, off-the-shelf natural killer (NK) cell therapies for the treatment of autoimmune diseases.

The company is working to harness the natural capabilities of NK cells to target and eliminate disease-driving cells, including dysfunctional B cells implicated in a range of autoimmune conditions. Its approach utilizes donor-derived cells with the goal of developing readily available, off-the-shelf cell therapies that may ultimately be administered in more accessible outpatient and community healthcare settings.

Our client is seeking a collaborative and driven clinical operations leader who is excited by the opportunity to help advance a novel cell therapy platform and contribute to the continued growth of its clinical development organization.

Overview

The Director of Clinical Trial Operations works closely with the Headof Clinical Operations and the broader clinical and leadership teams to lead the strategic planning, execution, and delivery of one or more clinical trials or programs.

The role provides operational leadership and decision-making authority for assigned clinical programs and/or studies, drives cross-functional alignment, and oversees internal and external resources to ensure trial delivery aligns with corporate objectives, timelines, budgets, and quality standards.

This individual may provide mentorship, guidance, and line management to less senior Clinical Operations staff. Partnership with key internal and external stakeholders will be critical to enabling high-quality, efficient, and compliant clinical trial delivery.

The Director will work closely with investigative site personnel, CROs, and other study vendors and will help ensure clinical trial activities are conducted in accordance with applicable SOPs, GCP, ICH, FDA, and global regulatory requirements.

Responsibilities

• Lead overall study or program deliverables, maintaining strategic oversight throughout the lifecycle of assigned studies or programs and ensuring delivery aligns with corporate and development goals.

• Coordinate activities across various phases of clinical studies, including study planning, site qualification and selection, monitoring, data review and cleaning, and closeout.

• Maintain study timelines and identify and communicate trial issues that may impact budgets, resources, and/or timelines.

• Lead risk management and mitigation planning to ensure delivery against quality, budget, and timeline expectations, implementing contingency strategies as necessary.

• Oversee performance management and governance of CROs and other outsourced clinical partners.

• Lead the selection, management, and performance oversight of external vendors, including CROs and clinical laboratories.

• Lead the development and review of essential study documents, including study protocols, informed consent forms, case report forms, and clinical study reports.

• Develop, review, and approve clinical study plans, manuals, presentations, and other study documentation, including country- and site-specific materials and tracking tools.

• Support user acceptance testing, sample and investigational product tracking, and other study-related operational activities as required.

• Identify and recruit clinical investigators and build strong working relationships with key opinion leaders and principal investigators.

• Train investigators and investigative site staff.

• Participate in internal clinical data review activities.

• Oversee external vendor management, including review of invoices against contractual agreements.

• Lead the development of technical specifications for vendors, including scopes of work, specifications, procedural manuals, and related documents.

• Support additional activities required for the successful execution of assigned clinical programs.

• Lead the creation and implementation of departmental procedures, best practices, standards, and scalable processes in compliance with industry and regulatory requirements.

• Oversee clinical study sites, including review of reports related to site qualification, initiation, monitoring, and closeout visits.

• Provide leadership, mentorship, and guidance to Associate Directors, Clinical Trial Managers, and other Clinical Operations team members; may include direct line management responsibility.

• Represent Clinical Operations in cross-functional program and leadership team meetings, providing input into program strategy, resourcing, and risk assessment.

• Own study and program budget management, including forecasting, accruals, and variance analysis in partnership with Finance.

• Contribute to broader organizational goals and initiatives as assigned.

• Travel domestically and internationally approximately 20% as required.

Qualifications

• Experience in cell therapy, oncology, or complex biologics is required ; experience in autoimmune indications is strongly preferred.

• Minimum of 7 years of experience managing and executing clinical trials within a biotechnology, pharmaceutical, or CRO environment, including demonstrated leadership across multiple studies or programs.

• Demonstrated experience mentoring, developing, or managing Clinical Operations staff preferred.

• Proven track record of independently leading complex, multi-site clinical trials from study start-up through closeout.

• Thorough knowledge and understanding of GCP, ICH, FDA, and applicable global regulatory requirements.

• Strong understanding of clinical trial terminology and operational processes.

• Excellent planning and organizational skills.

• Strong critical-thinking, troubleshooting, and problem-solving abilities.

• Excellent written and verbal communication skills, including presentation capabilities.

• Ability to develop and maintain strong working relationships with internal colleagues and external stakeholders, including investigators, key opinion leaders, vendors, and senior leadership.

• Ability and willingness to travel domestically and internationally approximately 20%.

• Self-motivated with the ability to prioritize and manage a high volume of work while maintaining strong attention to detail.

• Flexible, collaborative, and solutions-oriented.

• Candidates located in the Greater San Francisco Bay Area who are able to work a hybrid schedule in South San Francisco are preferred.

Education

• BS/BA degree in a related discipline and a minimum of 10 years of related experience; or

• MS/MA degree in a related discipline and a minimum of 7 years of related experience; or

• PhD in a related discipline and a minimum of 5 years of related experience; or

• An equivalent combination of education and relevant professional experience.

Compensation

Base salary range: $220,000–$270,000 USD