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Nkarta

Develops NK cell-based cell therapies

Senior Director/Executive Director, Head of Clinical Data Management - Clinical Data Management

Clinical Research OperationsConfirmed live in the last 24 hours
Full-timeSouth San Francisco, CA, USA

About the Job

Requirements

  • A Bachelor of Science, Bachelor of Arts, and/or Master of Science degree in a science- or health-related field, or an equivalent combination of education and experience.
  • At least 12 years of clinical data management experience in the pharmaceutical or biotechnology industry; at least 15 years for the Executive Director level, including at least 5 years leading a CDM function or CDM for a major program.
  • Demonstrated leadership of data management through database lock for a pivotal (Phase 3 or registrational) study, and CDM contribution to at least one marketing application (BLA, NDA or MAA).
  • Deep knowledge of CDM processes, EDC systems including Medidata Rave, database build and change control, data validation, external data reconciliation, MedDRA and WHODrug coding, quality management, and current CDM technology.
  • Strong knowledge of GCP, CDISC standards including CDASH and SDTM, FDA and ICH guidelines, and CDM best practices.
  • Proven sponsor-side oversight of CROs and data vendors, including scope, budget, and performance management.
  • Demonstrated success building or transforming a sponsor-side CDM operating model in a resource-lean biotechnology organization, including rapid amendments, multi-indication studies, and frequent interim data cuts.
  • Demonstrated line-management experience, with the ability to lead and inspire CDM employees, consultants, and external partners.
  • Outstanding problem-solving, influencing, negotiation, and communication skills; strong attention to detail; and the ability to manage multiple priorities in a fast-paced, resource-lean environment.

Responsibilities

  • 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 appropriate 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, and 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 data are clinically meaningful, traceable, and fit for analysis and regulatory use.
  • Participate in protocol development and amendment review to ensure protocol requirements can be collected, cleaned, and analyzed; drive CRF and EDC design accordingly.
  • Own EDC change control for protocol amendments, including specifications, edit checks, user acceptance testing, 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 to identify trends in delayed entry, unresolved queries, and recurring vendor or site issues; lead root-cause analysis and corrective actions.
  • Provide sponsor oversight of the biometrics CRO, data management contractors, and other data vendors by defining scope, key performance indicators, sponsor acceptance criteria, and escalation pathways; review deliverables against specification and drive remediation of performance issues.
  • Lead selection, auditing, and onboarding of CDM and Biometrics vendors, including vendor strategy for pivotal and global studies.
  • Oversee the quality and integrity of clinical trial data from third-party vendors such as CROs, central and specialty labs, eCOA/ePRO, imaging, and IRT; review vendor data for accuracy, completeness, and timeliness and resolve discrepancies. Own CDM resource planning, budget forecasting, and change-order review.
  • Lead creation and continuous improvement of CDM Global Standard Operating Procedures, work instructions, and standards aligned with CDISC (CDASH/SDTM), GCP, GCDMP, 21 CFR Part 11, applicable data privacy requirements, and ICH E6 guidelines.
  • Maintain complete, current, inspection-ready CDM documentation in the Trial Master File, including eCRF specifications and completion guidelines, annotated CRFs, data validation specifications, data transfer agreements, data management plans, and change-control logs, with traceable evidence that data management controls operated effectively.
  • Prepare the CDM function and its vendors for BLA submission, regulatory inspection, and audit; lead CDM responses to audit findings and quality events.
  • Recruit, develop, and lead CDM employees and consultants; set clear expectations, coach for growth, and create a team culture of accountability and data quality.
  • At Executive Director level, take on broader scope including portfolio-wide data standards, systems and analytics, ex-US CDM strategy, and greater organizational leadership and enterprise influence.

Desired Qualifications

  • Experience in immunology or rheumatology, cell therapy, gene therapy, or other complex biologics.
  • Experience with complex composite and responder endpoints, patient-reported outcomes, and external data sources such as central laboratory, imaging, cell-product, and biomarker data.
  • Experience preparing a CDM function for a first BLA and regulatory inspection in a small or mid-sized company.
  • Experience supporting global (US and EU) clinical studies.

About the Company

Nkarta

Develops NK cell-based cell therapies

Nkarta develops next-generation cell therapies using natural killer (NK) cells to treat cancer and autoimmune diseases. The company expands and enhances NK cells with proprietary technology to improve their ability to locate and destroy tumor cells, then uses these optimized cells as therapeutic products. Its approach relies on research and development, clinical trials, and eventual commercialization, with revenue coming from partnerships, licensing agreements, and future product sales. Nkarta differentiates itself by leveraging its focused NK cell expansion and optimization capabilities to improve efficacy, tolerability, and accessibility of cell therapies. The company aims to make potent, well-tolerated NK cell therapies more broadly available to patients in need.

Company size
51-200
Company stage
IPO
Headquarters
South San Francisco, CA
Founded
2015

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