Executive Director, Clinical Data Management

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Dianthus Therapeutics, Inc.

WebsiteLinkedInAll Job Openings

1 - 10 employees

Founded 2017

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

💰 $100M Private Equity Round on 2022-04

Healthcare • Biotechnology • Pharmaceuticals

Dianthus Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing novel monoclonal antibodies to treat severe autoimmune and inflammatory diseases. The company leverages advanced antibody engineering technologies to create next-generation complement therapeutics with improved selectivity and potency. Its lead program, DNTH103, is a monoclonal antibody targeting the classical complement pathway for conditions such as generalized Myasthenia Gravis, Multifocal Motor Neuropathy, and Chronic Inflammatory Demyelinating Polyneuropathy. Based in New York City and Waltham, Massachusetts, Dianthus aims to deliver transformative medicinal therapies by addressing unmet needs in autoimmune treatment.

📋 Description

• Lead and scale the Clinical Data Management function, establishing the strategy, organizational structure, and roadmap to support Dianthus' growing clinical portfolio. • Build, develop, and mentor a high-performing team while fostering a culture of accountability, collaboration, innovation, and operational excellence. • Establish and maintain departmental SOPs, processes, governance frameworks, quality standards, and inspection-ready practices. • Provide leadership and oversight for all data management activities across clinical studies, ensuring the delivery of high-quality, complete, and regulatory-compliant data. • Manage and strengthen strategic relationships with CROs, vendors, and external partners, ensuring performance, quality, and operational excellence. • Drive the evaluation, implementation, and optimization of data management systems, technologies, and processes to improve efficiency, scalability, and data quality. • Partner cross-functionally with Clinical Operations, Biostatistics, Statistical Programming, Medical, Safety, Regulatory, and Quality teams to support study execution, regulatory submissions, and key business decisions. • Ensure compliance with GCP, ICH, FDA, and global regulatory requirements while maintaining inspection readiness and supporting regulatory submissions. • Serve as the Clinical Data Management subject matter expert and leadership representative across cross-functional and senior leadership forums. • Remain actively engaged in study-level execution and problem-solving, balancing strategic leadership with hands-on operational support in a fast-paced biotechnology environment.

🎯 Requirements

• Bachelor's degree in Life Sciences, Computer Science, Biostatistics, Health Sciences, or related discipline; advanced degree preferred. • 15+ years of Clinical Data Management experience within biotechnology, pharmaceutical, or CRO environments. • 8+ years of progressive leadership experience managing Clinical Data Management teams and functional operations. • Experience building, scaling, or transforming Clinical Data Management organizations, processes, and operating models. • 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, clinical databases, CDISC standards, medical coding, external data integration, and reconciliation processes. • Deep understanding of drug development, GCP, ICH guidelines, and global regulatory requirements. • Experience supporting major regulatory submissions, including NDA, BLA, and/or MAA filings. • Proven ability to influence senior leadership and drive cross-functional alignment in a matrix environment.

🏖️ Benefits

• None specified