Director, Clinical Trial Operations

Overview

The Director of Clinical Trial Operations works closely with the Executive Director of Clinical Operations and the 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 aligned with corporate objectives, timelines, budgets, and quality standards. This role may provide mentorship, guidance, and line management to less senior clinical operations staff. Partnership with key internal and external stakeholders is critical to enable high-quality, efficiency, and compliant clinical trial delivery. This role works closely with investigative site personnel, CROs, and other study vendors and helps ensure clinical trial activities are conducted in accordance with Standard Operating Procedures, GCP, ICH, FDA, and applicable global regulatory requirements.

Responsibilities

• Lead overall study or program deliverables, maintaining strategic oversight throughout the life of the study or program(s) and ensuring delivery aligned with corporate and development goals
• Coordinate activities within various phases of clinical studies (i.e. study planning, site qualification and selection, monitoring, data review and cleaning, closeout, etc.).
• Maintain study timelines, including identifying and communicating trial issues that will impact budget, resources and/or timelines.
• Lead risk management and mitigation plans to ensure delivery to quality, budget, and timelines, and implement contingency strategies as needed.
• Oversee performance management and governance of CROs and other clinically outsourced third-party vendors for outsourced studies and programs
• Lead selection, management, and performance oversight of other external vendors (e.g. CROs, clinical labs, etc.).
• Lead the development and review of essential study documents (study protocol, ICF, Case Report Forms, Clinical Study Reports, etc.).
• Develop, review, and approve clinical study plans, manuals, presentations, and other study documents (country/site specific ICF’s, site facing documents and tracking tools), assist with user acceptance testing, sample and product tracking, and other activities as needed.
• Identify and recruit clinical investigators. Build and maintain strong working relationships with KOLs and PIs. Train investigators and investigative site staff.
• Participate in in-house data review.
• Oversee external vendor partner management, including review of invoices for accuracy compared to vendor contract. Lead the development of technical specifications for vendors (e.g. scope of work, review and approval of specifications, procedural manuals, etc.).
• Handle other duties and responsibilities to support successful execution of assigned clinical programs.
• Lead the creation and implementation of departmental procedures, best practices, standards, and scalable processes in compliance with industry standards and regulatory requirements.
• Oversee clinical study sites, including up to 20% travel; review reports for PSSVs, SIVs, IMVs, and COVs as required
• Provide leadership, mentorship, and guidance to Associate Directors, Clinical Trial Managers, and other clinical operations team members; may have 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/program budget management, including forecasting, accruals, and variance analysis in partnership with Finance.
• Contribute to wider organizational goals and/or activities as assigned.

Qualifications

• Experience in cell therapy, oncology, or complex biologics required; experience in autoimmune indications is a plus.
• Minimum 7 years of experience in the management and execution of clinical trials at a sponsor or CRO, including leadership demonstrated 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 start-up through closeout.
• Thorough knowledge and understanding of GCP, ICH, FDA, and applicable global regulatory requirements and medical terminology for clinical trials.
• Excellent planning and organizational skills.
• Ability to think critically and demonstrated troubleshooting and problem-solving skills.
• Excellent written and oral communication skills, including presentation skills.
• Ability to develop and maintain excellent working relationships with both internal colleagues and external contacts, including key thought leaders, investigators, and senior stakeholders.
• Able and willing to travel domestically and internationally (approximately 20%).
• Must be self-motivating, prioritize and manage a large volume of work, and show attention to detail.
• Flexible and solution focused.
• Prefer candidate that is located in the Greater San Francisco area and able to work a hybrid schedule in the South San Francisco office.
• Embodies the Nkarta culture of empowerment, diversity, and inclusion.

Education

• BS/BA degree in related discipline and a minimum of 10 years of related experience; or,
• MS/MA degree in related discipline and a minimum of 7 years of related experience; or,
• PhD in related discipline and a minimum of 5 years of related experience; or,
• Equivalent combination of education and experience