Director / Senior Director, Clinical Development Scientist

September 24

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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 scientific lead on assigned Phase III/late-stage trial(s): define protocol and endpoints, author or review regulatory‐relevant documents, ensure protocol integrity and compliance • Collaborate cross-functionally (clinical operations, biostatistics, regulatory, safety) to drive operational feasibility, site selection, study start-up, and execution across regions • Oversee safety and efficacy data monitoring: identify trends, support medical monitoring, work with DSMBs/DMCs, ensure timely reporting and regulatory compliance • Support and contribute to the development and refinement of the overall Clinical Development Plan and associated evidence generation strategy • Maintain and apply knowledge of disease biology, competitive landscape, therapeutic modalities, and regulatory/scientific advancements relevant to the therapeutic area • Facilitate external relationships: sites, investigators, KOLs, CROs, regulatory agencies • Provide mentorship, guidance, and scientific oversight to team members on scientific content and trial execution • Produce and support publications, presentations, and internal/external communications of trial findings and strategic insights • Ability to travel 15-20%

🎯 Requirements

• Advanced degree in life/health sciences (PhD, PharmD, MD, MPH or equivalent) • Experience supporting global Phase III pivotal trials • Deep understanding of rare disease, neurology, immunology, or a closely related field • Extensive knowledge of drug development processes (late-phase trials), GCP/ICH standards, clinical operations, study design, safety monitoring, and statistics • Demonstrated experience drafting and reviewing protocols, regulatory documents, medical monitoring plans, safety reports • Excellent scientific writing ability and meticulous attention to detail • Strong skills in data review, trend identification, data interpretation, and safety oversight, including experience with DSMBs/DMCs • Effective written and verbal communication skills; ability to engage internal teams, investigators, CROs, regulatory bodies, and external experts • Strategic mindset with ability to balance long-term goals and tactical needs • Experience working across geographies and multimodal teams; capable of influencing without direct authority • Proficiency in Microsoft Office, EDC systems, data platforms • Ability to travel 15-20%

🏖️ Benefits

• We are open to you working remotely.