Executive Director, Clinical Data Management

Dianthus Therapeutics is a biotechnology company dedicated to developing innovative therapies for patients with severe autoimmune diseases. We are seeking an experienced Executive Director of Clinical Data Management to lead the development and evolution of our data management function, ensuring the delivery of high-quality, regulatory-compliant data to support our growing clinical portfolio.

Key responsibilities

• Lead and scale the Clinical Data Management function, establishing the strategy, organizational structure, and roadmap for our clinical programs.
• Build, develop, and mentor a high-performing team while fostering a culture of accountability, innovation, and operational excellence.
• Establish and maintain departmental SOPs, governance frameworks, and quality standards to ensure inspection-ready practices.
• Provide leadership and oversight for all data management activities, ensuring the delivery of complete and regulatory-compliant data.
• Manage strategic relationships with CROs and external partners to ensure performance and quality.
• Partner cross-functionally with Clinical Operations, Biostatistics, and Regulatory teams to support study execution and business decisions.

Requirements

• Bachelor's degree in Life Sciences, Computer Science, or a related discipline; an advanced degree is preferred.
• 15+ years of Clinical Data Management experience within the biotechnology, pharmaceutical, or CRO sectors.
• 8+ years of progressive leadership experience managing teams and functional operations.
• Proven success in building or transforming Clinical Data Management organizations and operating models.
• Strong experience overseeing outsourced data management activities and Phase 2/3 clinical programs.
• Comprehensive knowledge of EDC systems, CDISC standards, and global regulatory requirements including GCP and ICH guidelines.
• Experience supporting major regulatory submissions such as NDA, BLA, or MAA filings.

What we offer

• The opportunity to lead and shape a critical function within a fast-paced, innovative biotechnology company.
• A highly visible leadership role with the ability to influence strategic direction and organizational growth.
• A collaborative environment focused on developing best-in-class therapies to improve patient lives.
• Full remote work flexibility to support your professional and personal balance.