Job Description
About Us
We are developing potentially best in class therapies for patients living with severe autoimmune diseases. Our lead antibody, claseprubart (DNTH103), is purposefully engineered with extended half-life, improved potency, and high selectivity for only the active C1s complement protein that drives disease pathology – enabling less frequent and more convenient self-administered subcutaneous injections. Our second clinical candidate, DNTH212 is a first and potentially best in class, bifunctional inhibitor that targets clinically validated and complementary disease modifying mechanisms, Type 1 IFN suppression and B cell modulation – enabling potential for improved clinical outcomes and patient friendly convenient, self-administered subcutaneous injections. To learn more, please visit www.dianthustx.com and follow us on LinkedIn.
About the Role
Dianthus Therapeutics is seeking an accomplished and strategic Executive Director, Clinical Data Management to lead the development, execution, and long-term evolution of our Clinical Data Management function. Reporting to the Senior Vice President, Clinical Development Operations, this individual will establish the vision, organizational structure, systems, processes, and operating model needed to support a growing clinical development portfolio.
As the functional leader for Clinical Data Management, the Executive Director will be responsible for building and scaling the department, developing talent, establishing SOPs and governance frameworks, and ensuring the delivery of high-quality, regulatory-compliant clinical data to support critical business decisions, regulatory submissions, and future commercialization efforts.
This is a highly visible leadership role requiring both strategic and operational expertise. While responsible for setting departmental direction and building organizational capabilities, the Executive Director will also remain actively engaged in study-level execution, vendor oversight, and cross-functional collaboration in a fast-paced biotechnology environment.
We are building a culture of individuals who hold our core principles at the center of our operations, with the goal to elevate the care of our patients’ lives. We are open to you working remotely.
Key Responsibilities
- 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.
Experience
- 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.
