Medical Director, Drug Safety and Pharmacovigilance

November 14

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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

• Serve as the safety physician lead for designated Dianthus’s product. • Conduct medical review of individual case safety reports (ICSRs), including seriousness, expectedness, and causality assessment, ensuring appropriate coding and compliance with global regulations. • Perform aggregate data analysis and interpretation. • Author and provide medical input to safety related regulatory documents such as periodic safety reports (e.g., DSURs, ASRs, PSUR, PADERs, etc.) or other deliverables as appropriate. • Contribute to / lead safety review committee activities, including individual and aggregate data analyses, signal detection and evaluation, interpretation of safety signals and trends, and documentation and communication of safety assessments. • Contribute to relevant clinical and regulatory documents, such as study protocols, investigator brochures, statistical analysis plan, and clinical study reports. • Collaborate with relevant functions such as clinical development, data management, regulatory affairs, biostatistics, and medical affairs on relevant safety issues. • Review and summarize relevant scientific and clinical literature to support safety evaluations and regulatory submissions • Support the senior medical director / designee on complex pharmacovigilance tasks/activities such as integrated safety analyses, benefit–risk assessments, and development of risk management strategies. • Support internal and external pharmacovigilance audits and regulatory inspections. • Stay current with global pharmacovigilance regulations, guidelines, and best practices.

🎯 Requirements

• MD, DO, or U.S. equivalent required, along with at least 3 years of industry pharmacovigilance (PV) experience as a safety physician. • Experience in neurology, immunology, and rare disease preferred. • Experiences in early and late phase clinical trials preferred. • Strong pharmacovigilance with signal management (e.g., signal detection, evaluation, assessment). • Ability to lead and conduct individual safety case report processing, including triage, medical review and safety data summarization and analysis. • Competent knowledge and understanding of international safety reporting and pharmacovigilance requirements and signal detection. • Knowledge of and ability to apply pre- and post-marketing drug safety standards. • Proficient with safety databases (Argus preferred) and safety coding dictionaries (e.g., MedDRA, WHODRUG). • Excellent problem-solving, analytical thinking skills. • Excellent interpersonal skills and ability to work effectively as part of a team/ Ability to build strong relationships with co-workers of various backgrounds and expertise.

🏖️ Benefits

• Open to remote work