Director - Senior Director, Medical Writing

March 1

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Dianthus Therapeutics, Inc.

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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 medical writing function and oversee document development for regulatory submissions and publications. • Build and manage writing teams, ensuring high quality and compliance of clinical documentation. • Work collaboratively across functions and support timely responses to regulatory inquiries. • Develop templates and quality control measures to maintain consistency in submissions. • Engage in strategic planning and process improvements to optimize writing deliverables. • Coach and mentor both internal and external writing resources.

🎯 Requirements

• 12+ years’ experience in a medical writing capacity within drug development • Working knowledge of clinical research, study design, pharmacology, biostatistics, regulatory requirements, and medical terminology • Experience leading medical writing teams responsible for global marketing authorization applications • Exceptional information gathering and conceptual skills • Ability to analyze, interpret, and summarize highly complex data • Outstanding project management and organizational skills • Adept at facilitating the open exchange of ideas and opinions to achieve consensus • Ability to work effectively under pressure and meet time-sensitive deadlines • Demonstrated experience mentoring medical writers, managing project work, and supervising internal and external writers • Proficient in the use of MS Word, Endnote, Adobe Acrobat, PleaseReview, and structured document templates • Experience with inspection readiness activities and representing MW during GCP inspections • Proactive team player, collaborative, resourceful, and flexible