Associate Director, Clinical Trial Operations

Overview

The Associate Director, Clinical Trial Operations works closely with the Executive Director of Clinical Operations and the clinical and leadership teams to support successful planning, execution, and delivery of clinical trials. The role manages operational activities for assigned clinical programs, oversees internal and external resources, and helps ensure trial delivery aligned with corporate objectives, timelines, budgets, and quality standards. Partnership with key internal and external stakeholders is critical to enable high-quality, efficient, 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

• Manage overall study or program deliverables, maintaining oversight throughout the life of the study or program 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
• Assist in selection, management and performance oversight of other external vendors (e.g. CROs, clinical labs, etc.).
• Participate in development of essential study documents (study protocol, ICF, Case Report Forms, Clinical Study Reports, etc.), as appropriate.
• 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.
• Helps identify and recruit clinical investigators. Builds and maintains great working relationships with KOLs and PIs. Trains investigators and investigative site staff.
• Participate in in-house data review.
• Assist with external vendor partner management, including review of invoices for accuracy compared to vendor contract. Coordinate and participate in 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.
• Assist in creating and implementing 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
• Contribute to wider organizational goals and/or activities as assigned.

Qualifications

• Experience in cell therapy, oncology, or complex biologics preferred; experience in autoimmune indications is a plus.
• Minimum 4 years experience in the management and execution of a clinical trial at a sponsor or CRO.
• 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 office in South San Francisco a couple of days per week, but this role can be local in South San Francisco or remote.
• Embodies the Nkarta culture of empowerment, diversity, and inclusion.

Education

• BS/BA degree in related discipline and a minimum of 8 years of related experience; or,
• MS/MA degree in related discipline and a minimum of 5 years of related experience; or,
• PhD in related discipline and a minimum of 4 years of related experience; or,
• Equivalent combination of education and experience

The common requirements of an office environment (computers, computer screens, workstations, etc.) apply. Car and airplane travel might be required for this role for conferences, meetings and site visits. This role can be local in South San Francisco or remote.