Associate Director, Data Review

November 5

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Dianthus Therapeutics, Inc.

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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.

2 - 10 employees

Founded 2017

🧬 Biotechnology

💊 Pharmaceuticals

💰 $100M Private Equity Round on 2022-04

📋 Description

• 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.

🎯 Requirements

• 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.

🏖️ Benefits

• We are open to you working remotely.