Senior Director/Executive Director, Clinical Data Management

Nkarta, Inc.•South San Francisco, CA

1d•$285,000 - $330,000•Hybrid

About The Position

Nkarta is seeking a Senior Director or Executive Director to serve as Head of Clinical Data Management (CDM). This hands-on leadership role 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 pivotal trials and a future Biologics License Application (BLA). The role ensures protocol changes are reflected promptly and accurately in clinical databases, data are ready for frequent analysis cuts, and the function can deliver submission-quality databases for pivotal studies. Reporting to the VP, Program Management and Head of Clinical Trial Services, the leader will direct internal data managers and contract staff, oversee the biometrics CRO and data vendors, and work closely with Clinical Development, Clinical Operations, Biostatistics, Drug Safety, Medical Writing, Regulatory Affairs, and other partners. The position sets portfolio-wide data strategy and governance, oversees study data delivery and database locks, manages vendor performance and budgets, and ensures quality, compliance, and inspection readiness. At the Executive Director level, the role has broader responsibility for portfolio-wide data standards, systems and analytics, ex-US CDM strategy, and organizational leadership.

Requirements

BS/BA and/or MS 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 Executive Director.
At least 5 years leading a CDM function or CDM for a major program.
Experience leading data management through database lock for a pivotal (Phase 3 or registrational) study and contributing CDM work 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.
Sponsor-side CRO and data-vendor oversight experience, including scope, budget, and performance management.
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.
Line-management experience and ability to lead and inspire CDM employees, consultants, and external partners.
Strong problem-solving, influencing, negotiation, and communication skills; attention to detail; and ability to manage multiple priorities in a fast-paced, resource-lean environment.

Nice To Haves

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.

Responsibilities

Set the vision, strategy, and operating model for Clinical Data Management across Nkarta clinical studies.
Establish portfolio-wide clinical data governance, including data ownership, standards, system interoperability, and decision rights.
Scale the CDM function from the current Phase 1/2 portfolio to future pivotal studies and BLA readiness, balancing internal, contract, and CRO resources.
Define and execute a pivotal-readiness roadmap covering 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 raise risks with recommendations.
Represent CDM on program teams and leadership forums, driving cross-functional data strategy with relevant internal functions.
Participate in protocol development and amendment review; ensure protocol requirements can be collected, cleaned, and analyzed; and guide CRF and EDC design.
Own EDC change control for protocol amendments, including specifications, edit checks, UAT, migration, and release.
Develop and maintain data management plans for collection, processing, medical coding, reconciliation, review, and storage.
Own external data-flow strategy, including transfer specifications and agreements, validation, traceability, reconciliation, exception handling, and timely availability of vendor data.
Plan and deliver clean data snapshots and locked databases for interim analyses, safety and data monitoring committee reviews, presentations, regulatory submissions, and study close-out.
Lead cross-functional data review, query and discrepancy management, and root-cause resolution of data issues.
Establish risk-based data-quality oversight, identify trends, and lead root-cause analysis and corrective actions.
Oversee biometrics CROs, data-management contractors, and other vendors; define scopes, KPIs, acceptance criteria, and escalation pathways; review deliverables and address performance issues.
Lead selection, auditing, and onboarding of CDM and Biometrics vendors, including vendor strategy for pivotal and global studies.
Review third-party clinical data for accuracy, completeness, and timeliness and resolve discrepancies.
Own CDM resource planning, budget forecasting, and change-order review.
Create and continuously improve CDM GSOPs, work instructions, and standards aligned with applicable industry standards and regulations.
Maintain complete, current, inspection-ready CDM documentation in the Trial Master File, with traceable evidence that controls operated effectively.
Prepare the CDM function and 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 expectations, coach team members, and foster accountability and data quality.