Senior Director/Executive Director, Clinical Data Management

nkartatherapeutics; South San Francisco (CA); On-site; USD 260,000 - 420,000; Full time

Job summary

In this hands-on leadership role, you will own the CDM strategy, operating model, data governance, and vendor management across Phase 1/2 studies and potential pivotal trials, ensuring data quality and regulatory readiness.

Responsibilities

• Set vision and operating model for CDM across Nkarta studies.
• Oversee data governance, data standards, and system interoperability.
• Lead staff and CRO resources for scalable CDM from Phase 1/2 to pivotal trials.
• Ensure data quality, inspection-ready documentation and regulatory readiness.

Skills

CDM leadership

Clinical data management

Strategic planning

Tools

EDC systems

Job description

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.

THE OPPORTUNITY

Nkarta is seeking a Senior Director or Executive Director to serve as Head of Clinical Data Management (CDM). This is a hands-on leadership role for an experienced data management executive who will own the strategy, operating model, and quality of clinical data across the NKX019 autoimmune program-from ongoing multi-indication Phase 1/2 studies through potential future pivotal trials and a Biologics License Application (BLA).

WHAT YOU'LL DO

Strategic Direction & Functional Leadership Serve as Head of Clinical Data Management and set the vision, strategy and operating model for CDM across all Nkarta clinical studies. Establish portfolio-wide clinical data governance covering data ownership, standards, system interoperability and decision rights across internal functions and external partners. Build a CDM function that scales from the current Phase 1/2 portfolio to future pivotal studies and BLA readiness, with the right balance of in-house, contract and CRO resources. Define and execute a pivotal-readiness roadmap before study initiation, encompassing data standards, system architecture, vendor capabilities, resourcing, quality controls and inspection-ready documentation. Align CDM plans, resources and timelines with corporate objectives and study milestones; flag risks early with recommendations. Represent CDM on program teams and in leadership forums, and drive cross-functional data strategy with Clinical Development, Biostatistics, Clinical Operations, Regulatory Affairs, Drug Safety, Translational Medicine and Medical Writing so that data are clinically meaningful, traceable and fit for analysis and regulatory use.

Study Data Delivery & Database Lock Participate in protocol development and amendment review to ensure that what the protocol requires can be collected, cleaned and analyzed; drive CRF and electronic data capture (EDC) design accordingly. Own EDC change control for protocol amendments-specifications, edit checks, user acceptance testing (UAT), migration and release-delivered on time without loss of data integrity. Develop and maintain data management plans covering data collection, processing, medical coding, reconciliation (including SAE and central laboratory data), review and storage. Own the end-to-end strategy for external data flows, including transfer specifications and agreements, ingestion validation, traceability, reconciliation, exception handling and timely availability of laboratory, imaging, biomarker, safety and cell-product data. Plan and deliver clean data snapshots and locked databases, as appropriate, for interim analyses, safety and data monitoring committee reviews, congress presentations, regulatory submissions and study close-out. Lead cross-functional data review with Clinical Development, Biostatistics and Drug Safety; direct discrepancy and query management and resolve data issues at their root. Establish risk-based data quality oversight that identifies trends in delayed