Executive Director, Clinical Data Management

About the Company

Dianthus Therapeutics is developing potentially best in class therapies for patients living with severe autoimmune diseases. Their lead antibody, claseprubart (DNTH103), is engineered for improved potency and high selectivity, enabling more convenient self-administered subcutaneous injections.

Responsibilities

• Lead and scale the Clinical Data Management function, establishing strategy, organizational structure, and roadmap
• Build, develop, and mentor a high-performing team while fostering a culture of accountability and innovation
• Establish and maintain departmental SOPs, processes, governance frameworks, and quality standards
• Provide leadership and oversight for all data management activities across clinical studies
• Manage and strengthen strategic relationships with CROs, vendors, and external partners
• Drive the evaluation, implementation, and optimization of data management systems and technologies
• Partner cross-functionally with Clinical Operations, Biostatistics, Medical, Safety, and Regulatory teams
• Ensure compliance with GCP, ICH, FDA, and global regulatory requirements
• Serve as the Clinical Data Management subject matter expert in senior leadership forums
• Remain actively engaged in study-level execution and problem-solving

Requirements

• Bachelor's degree in Life Sciences, Computer Science, Biostatistics, or related discipline
• 15+ years of Clinical Data Management experience in biotech, pharma, or CRO environments
• 8+ years of progressive leadership experience managing Clinical Data Management teams
• Experience building, scaling, or transforming Clinical Data Management organizations
• Demonstrated success supporting Phase 2 and Phase 3 clinical programs
• Strong experience overseeing outsourced data management activities and CRO partnerships
• Comprehensive knowledge of EDC systems, CDISC standards, and medical coding
• Deep understanding of drug development, GCP, ICH guidelines, and global regulatory requirements
• Experience supporting major regulatory submissions (NDA, BLA, or MAA filings)