What are the responsibilities and job description for the Associate Director, Data Review position at Dianthus Therapeutics, Inc.?
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
The Associate Director, Data Review will play a critical role in ensuring the integrity, accuracy, and completeness of clinical trial data.
You will lead bringing the data review process in-house from the CRO, oversee data review activities across multiple studies, work closely with CROs, CRAs, and internal cross-functional teams to ensure high-quality data that supports regulatory submissions and scientific publications. You must have experience as a CRA and ideally a healthcare background in order to be successful in this role.
This is an exciting opportunity to spearhead the transition and build our internal data review processes to ensure alignment across the development teams. 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
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
The Associate Director, Data Review will play a critical role in ensuring the integrity, accuracy, and completeness of clinical trial data.
You will lead bringing the data review process in-house from the CRO, oversee data review activities across multiple studies, work closely with CROs, CRAs, and internal cross-functional teams to ensure high-quality data that supports regulatory submissions and scientific publications. You must have experience as a CRA and ideally a healthcare background in order to be successful in this role.
This is an exciting opportunity to spearhead the transition and build our internal data review processes to ensure alignment across the development teams. 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 manage clinical data review activities across assigned studies.
- Collaborate with internal colleagues, clinical trial sites, and external vendors / partners to support data cleaning, query resolution, and database lock processes.
- Review clinical data platforms, listings and reports to identify inconsistencies, trends, and potential issues and communicate and / or present findings, trends or analyses to relevant cross functional team as required.
- Review, from a medical and clinical aspect, data, anomalies and protocol deviations and communicate and / or present findings, trends or analyses to relevant cross functional team as required.
- Partner with cross functional teams including Clinical Operations, Clinical Development, PV, Data Sciences and Biostatistics to ensure data quality and compliance.
- Contribute to, and implement, data review plans and contribute to data management plans.
- Participate in vendor oversight, including performance monitoring and issue resolution.
- Support audit readiness and regulatory inspections by ensuring data traceability and documentation.
- Mentor junior team members and contribute to process improvement initiatives.
- Registered Nurse (RN), or equivalent clinical/medical background (e.g., PA) strongly preferred.
- Experience in clinical research, including experience as a Clinical Research Associate (CRA) or in a data oversight role.
- Strong understanding of data platforms, clinical trial processes, GCP, and regulatory requirements.
- Experience working with CROs and managing outsourced data review activities.
- Strong experience in reviewing EDC systems and clinical data listings.
- Excellent analytical, organizational, and communication skills.
- Ability to work independently in a fast-paced, startup environment.