Executive Director, Clinical Data Management

🕒 May 5

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Kyverna Therapeutics

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2019

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

💰 $85M Series B on 2022-01

Biotechnology • Pharmaceuticals • Science

Kyverna Therapeutics is a patient-centered, clinical-stage biopharmaceutical company focused on developing cell therapies for patients suffering from autoimmune diseases. The company is pioneering CAR T-cell therapies, leveraging the transformational power of T cells to potentially provide sustained, treatment-free remission for autoimmune conditions. Kyverna's lead CAR T-cell therapy candidate, KYV-101, is advancing through clinical trials targeting various autoimmune diseases, including multiple sclerosis, myasthenia gravis, systemic sclerosis, and lupus nephritis. Their pipeline features innovative chimeric antigen receptor (CAR) T-cell therapies in both autologous and allogeneic formats aimed at B cell-driven autoimmune diseases.

📋 Description

• Define, lead and execute the global Clinical Data Management strategy, aligned with Kyverna’s clinical, regulatory and corporate objectives • Establish and evolve the CDM operating model, governance framework, resourcing strategy and organizational structure to support growth across programs and regions • Serve as a key member of the Clin Development Operations leadership team, contributing to enterprise-level planning • Lead the development and implementation of data standards, processes, and technologies, including CDISC and emerging industry best practices • Drive innovation in data collection, integration, and analytics, including adoption of modern tools and automation • Oversee standards governance, including management of deviations and continuous improvement initiatives • Champion a data-driven culture, enabling real-time insights and decision-making across clinical programs • Provide executive oversight of end-to-end CDM activities across all clinical studies, including: Study start-up planning, EDC/database and CRF design, Data validation, cleaning and reconciliation, Integration of external data (e.g. PK, biomarkers, etc..), Database locks and data transfers for analysis and submission • Ensure delivery of high-quality, inspection-ready clinical data in line with program timelines and regulatory expectations • Oversee development and review of key CDM deliverables, including, Data Management Plans (DMPs), edit check specifications, CRF design and completion guidelines and data review plans • Provide strategic oversight of CDM systems and platforms to ensure scalability, compliance, efficiency, and long-term fit. • Identify and drive opportunities for process optimization, automation, and innovation in data collection, integration, review and reporting. • Evaluate emerging technologies, including AI-enabled solutions, to enhance data quality, efficiency, and transparency • Ensure effective cross-functional data review and reconciliation across internal and external data sources • Define and execute CDM vendor strategy, including selection, oversight, and performance management of CRO partners • Provide senior-level oversight of vendor performances, including issue escalation, risk management, quality oversight, and continuous improvement • Build strong, collaborative relationships with external vendors to ensure quality, efficiency, and scalability • Drive accountability through KPIs, metrics, and governance frameworks • Ensure compliance with global regulatory requirements, including 21 CFR Part 11, ICH-GCP, and CDISC standards • Lead inspection readiness efforts for data management, including robust documentation, audit support and health authority interactions • Ensure all CDM processes, systems, and documentation meet regulatory and quality standards • Partner closely with Biostatistics, Statistical Programming, Clinical Operations, Clinical Development, Regulatory, and Quality to support INDs, amendments, DSURs, BLAs and post-marketing commitments • Provide strategic input into clinical development plans, regulatory submissions, and data deliverables • Influence cross-functional stakeholders to ensure timely and high-quality data delivery • Build, lead and mentor a high-performing Clinical Data Management organization • Foster a culture of ownership, collaboration, accountability, and continuous learning aligned with company values. • Develop succession plans and capability roadmaps to support organizational growth and future pipeline needs

🎯 Requirements

• BS/MS in Life Sciences, Data Management, Computer Science, or related field (advanced degree preferred) • 15+ years of progressive experience in clinical data management within biotech/pharma • 8+ years of leadership experience building, scaling and leading high-performing CDM teams in a clinical-stage company • Deep expertise in clinical data management, biometrics interfaces, clinical trial processes, and global regulatory expectations • Strong knowledge of CDISC standards, 21 CFR Part 11, ICH-GCP, and global regulatory requirements • Demonstrated experience defining and implementing data strategies, standards, and operating models across multiple studies and development stages • Proven ability to lead cross-functionally and influence in highly matrixed environments • Strong experience with CRO and vendor oversight, including managing complex vendor relationships • Experience supporting regulatory submissions and health authority inspections • Expertise in managing internal and external data sources (e.g., PK, ADA, biomarkers) • Familiarity with data visualization and reporting tools (e.g., SAS, R, JReview, Spotfire, Tableau, Power BI) • Strong leadership capabilities, including, strategic thinking and decision-making, organizational design and scaling, cross-functional influence and stakeholder management • Excellent executive communication skills and presence, ability to engage effectively with senior leadership and external stakeholders • Ability to thrive in a fast-paced, dynamic, and high-growth environment • Experience in cell therapy, immunology, oncology or autoimmune disease programs strongly preferred.

🏖️ Benefits

• This position is also eligible for bonus • benefits • participation in Company’s stock plan.