Manager/Senior Manager, Drug Safety Operations

November 19

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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

• Help lead and optimize operational aspects of pharmacovigilance across multiple clinical programs. • Responsible for vendor relationships, ensuring compliance with global safety regulations, and managing critical processes that support patient safety and regulatory reporting. • Oversee case processing activities, including intake, triage, and timely reporting of adverse events. • Maintain and monitor trackers for lab values and other safety-related data to ensure accurate and timely updates. • Ensure vendor compliance with contractual obligations, timelines, and quality standards. • Provide operational expertise during audits and inspections. • Ensure adherence to global PV regulations (FDA, EMA, ICH) and company SOPs.

🎯 Requirements

• Bachelor’s degree in life sciences or related field required; advanced degree preferred. • Minimum 7+ years in drug safety/pharmacovigilance operations within biotech or pharmaceutical industry. • Proven experience managing safety vendors and overseeing case processing activities. • Hands-on experience with pharmacovigilance agreements and safety database management. • Strong knowledge of global PV regulations and GVP guidelines. • Excellent organizational, communication, and vendor management skills. • Ability to thrive in a fast-paced, start-up environment.

🏖️ Benefits

• Open to you working remotely.