Executive Director, Clinical Data Management - Remote

8w2 months ago

Kyverna

Remote · Full-time · $265,000 – $295,000

About this role

Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company developing cell therapies for autoimmune diseases. The Executive Director, Clinical Data Management is a senior leadership role responsible for defining and executing global clinical data management strategy across the portfolio. This ensures delivery of high-quality, regulatory-compliant, inspection-ready clinical data from study start-up through database lock.

In a fast-paced, growth-stage environment, partner closely with Biostatistics, Statistical Programming, Clinical Operations, Regulatory, and external partners. Establish scalable CDM strategies, governance models, processes, and systems supporting the pipeline. Shape data standards, technologies, and operating models while building a high-performing data management organization.

Serve as a key member of the Clin Development Operations leadership team, contributing to enterprise-level planning. Champion a data-driven culture enabling real-time insights and decision-making across programs. Oversee end-to-end CDM activities including EDC design, data validation, external data integration, and database locks.

Drive innovation in data collection, integration, analytics, and adoption of modern tools like AI-enabled solutions. Ensure operational excellence, inspection readiness, and process optimization. Play a critical role in advancing Kyverna’s pipeline through data integrity and strategic oversight.

Requirements

Strategic leadership experience in clinical data management within biotech or biopharma
Expertise in establishing global CDM strategies, governance, and operating models
Proficiency in CDISC standards, data standards governance, and industry best practices
Knowledge of EDC systems, CRF design, data validation, cleaning, and reconciliation processes
Experience integrating external data such as PK and biomarkers
Track record overseeing database locks, data transfers, and regulatory submissions
Ability to drive process optimization, automation, and innovation in clinical data handling
Strong cross-functional collaboration with Biostatistics, Clinical Operations, and Regulatory teams

Responsibilities

Define, lead, and execute the global Clinical Data Management strategy aligned with clinical, regulatory, and corporate objectives
Establish and evolve the CDM operating model, governance framework, resourcing strategy, and organizational structure
Serve as a key member of the Clin Development Operations leadership team contributing to enterprise-level planning
Lead development and implementation of data standards, processes, and technologies including CDISC
Drive innovation in data collection, integration, analytics, and adoption of modern tools and automation
Provide executive oversight of end-to-end CDM activities across all clinical studies from start-up to database lock
Ensure delivery of high-quality, inspection-ready clinical data in line with timelines and regulatory expectations
Evaluate emerging technologies including AI-enabled solutions to enhance data quality, efficiency, and transparency

Benefits

Remote location offering flexible work arrangement
Join forefront of cell therapy innovation for autoimmune diseases
Collaborate in patient-centered, growth-stage biopharmaceutical environment
Guided by core values: Stay True to Why, Collaborate to Accelerate, Lead with Clarity