About Us
Nkarta is a publicly traded (Nasdaq symbol NKTX), clinical-stage biotechnology company headquartered in South San Francisco, focused on advancing the development of allogeneic, off-the-shelf natural killer (NK) cell therapies to treat autoimmune disease.
Founded in 2015, Nkarta is on a mission to harness the body’s natural killer cells – the immune system’s first responders – to deliver a safe, accessible form of cell therapy to treat B cell-mediated autoimmune diseases. Our vision is to make cell therapy more broadly available to patients by pioneering allogeneic NK cells that can be dosed in outpatient, community health settings.
Nkarta’s engineering process enhances the natural ability of NK cells to fight disease by identifying and eliminating unhealthy cells, including malfunctioning B cells at the root of many autoimmune conditions. Our lead NK cell therapy candidate, NKX019, uses NK cells collected from healthy donors rather than burdening the patient with a blood collection. Using donor-derived cells allows us to develop CAR NK cells off the shelf and on demand.
Nkarta is a people-driven company looking for passionate, collaborative, determined team members galvanized by a paradigm-shifting opportunity to change the cell therapy landscape.
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…