Executive Director, Clinical Data Management (Hybrid, SF)

Nkarta, Inc.

South San Francisco (CA)

Hybrid

USD 285,000 - 330,000

Full time

3 days ago
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Benefits offered by this job

Annual bonus
Equity grant
Medical insurance
Dental insurance
Vision insurance
401K
ESPP
Paid time off

Job summary

Nkarta, Inc. is seeking a Senior Director/Executive Director to lead Clinical Data Management (CDM) for the NKX019 autoimmune program, spanning Phase 1/2 to potential pivotal trials and a BLA.

The role combines strategic direction with hands-on leadership, guiding internal staff and CROs to deliver submission-ready data. The Head of CDM will ensure protocol changes are captured, data are analysis-ready, and data governance is positioned for regulatory success, with close collaboration across

Qualifications

  • BS/BA and/or MS in a science- or health-related field or equivalent experience.
  • 12+ years of clinical data management experience; 15+ years for Executive Director.
  • 5+ years leading a CDM function or CDM for a major program.
  • Deep knowledge of CDM processes, EDC systems, data validation, coding and quality management.
  • Strong knowledge of GCP, CDISC standards (CDASH/SDTM), FDA/ICH guidelines.
  • Sponsor-side oversight of CROs and data vendors including scope, budget and performance.

Responsibilities

  • Set vision and operating model for CDM across Nkarta clinical studies.
  • Establish portfolio-wide data governance and standards across internal and external partners.
  • Scale CDM function for future pivotal studies and BLA readiness.
  • Oversee data delivery, database lock, data cleaning and analysis-ready datasets.
  • Manage sponsor oversight of CROs, vendors and data integrations; ensure timely, high-quality deliverables.
  • Lead CDM for regulatory submissions and inspection readiness.

Skills

CDM leadership
EDC (Medidata Rave)
GCP & CDISC standards
Vendor management
Cross-functional collaboration
Data governance

Education

BS/BA or MS in science

Tools

Medidata Rave
CDISC tooling

Job description

Nkarta, Inc. is seeking a Senior Director/Executive Director to lead Clinical Data Management (CDM) for the NKX019 autoimmune program, spanning Phase 1/2 to potential pivotal trials and a BLA.

The role combines strategic direction with hands-on leadership, guiding internal staff and CROs to deliver submission-ready data. The Head of CDM will ensure protocol changes are captured, data are analysis-ready, and data governance is positioned for regulatory success, with close collaboration across

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