Senior Director, Medical Writing - Remote

Overview

Dianthus Therapeutics is a publicly traded, clinical-stage biotechnology company dedicated to designing and delivering novel, best-in-class monoclonal antibodies with improved selectivity and potency. Based in New York City and Waltham, Mass., Dianthus is comprised of an experienced team of biotech and pharma executives who are leading the development of next-generation antibody complement therapeutics, aiming to deliver transformative medicines for people living with severe autoimmune and inflammatory diseases.

In Short

• Lead the function of Medical Writing and shape communication of clinical data.
• Oversee Medical Writing teams and external vendors.
• Deliver high-quality clinical and regulatory documents.
• Participate in Rapid Response Teams for Health Authority requests.
• Develop templates and quality control checklists.
• Plan strategically and recommend process improvements.
• Manage budget and resources for medical writing deliverables.
• Coach and support internal and external writers.
• Act as subject matter expert for data transparency deliverables.
• Travel 10-15% for team meetings and events.

Requirements

• Advanced degree in life sciences preferred; minimum BS/BA required.
• 12+ years’ experience in medical writing within drug development.
• Knowledge of clinical research, study design, and regulatory requirements.
• Experience leading medical writing teams for global applications.
• Exceptional information gathering and conceptual skills.
• Ability to analyze and summarize complex data.
• Outstanding project management and organizational skills.
• Proficient in MS Word, Endnote, and Adobe Acrobat.
• Experience with inspection readiness activities.
• Proactive team player and flexible.

Benefits

• Opportunity to join a clinical-stage company.
• Build the Medical Writing function.
• Contribute to transformative medicines.
• Work in a culture centered on core principles.
• Remote work flexibility.