About Us

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. To learn more, please visit www.dianthustx.com and follow us on LinkedIn.

About the Role

As the Senior Director, Medical Writing, you will establish the function and play a ‘hands-on’ role in shaping the communication, the development, and the delivery of clinical and scientific data to regulatory agencies, healthcare professionals, and other stakeholders.

Reporting to the SVP, Regulatory affairs, you will be responsible for providing expertise to cross-functional teams throughout the product lifecycle. Key success factors for the position include proven track record in overseeing Medical Writing teams, external vendors, and the delivery of high-quality submission-ready documents (eg, INDs, filings, protocols, IBs, CSRs, etc.) and publications (abstracts, presentations, journal articles).

This is an exciting opportunity to join a clinical-stage company and help to build the function while contributing to many milestones as we continue to evolve. We are building a culture of individuals who hold our core principles at the center of our operations, with the goal to elevate the care of our patients' lives.

Key Responsibilities

• Lead writing strategy, drive document content and organization, develop and manage timelines, and identify relevant stakeholders
• Independently author and manage others in creation of clear and concise, submission-ready clinical and regulatory documents
• Advise on document development, ensuring adherence to regulations, ICH guidelines, and standard operating procedures (SOPs)
• Oversee medical writing resourcing to support publication plans and ensure consistency of messaging with clinical and regulatory submissions
• Coach, develop, and support writers (internal and external)
• Develop budget and resource strategies to ensure on schedule completion of medical writing deliverables using a mix of internal and external medical writers
• Act as subject matter expert for development of data transparency deliverables
• Develop and maintain SOPs, style guides, and quality control checklists that drive consistency across documents and processes
• Plan strategically, anticipate problems, and recommend process improvements to address current and future needs
• Ability to travel 10-15% for functional team meetings and company events

Experience

• Advanced degree in life sciences preferred; minimum BS/BA required
• 10 years’ experience in a medical writing capacity within drug development
• Prior direct experience leading medical writing teams responsible for global marketing authorization applications
• Exceptional information gathering and conceptual skills with ability to identify and solve complex problems
• Extensive knowledge of English grammar and American Medical Association style guide
• Demonstrated experience mentoring medical writers, managing project work, and supervising internal and external writers
• Well organized; able to prioritize tasks, work simultaneously on multiple projects, and complete high-quality documents according to tight timelines
• Experience with inspection readiness activities and representing MW during GCP inspections
• Working knowledge of biologics drug development, clinical research, study design, biostatistics, regulatory, and medical terminology
• Proactive team player, collaborative, resourceful, and flexible
• Strong interpersonal skills and the ability to collaborate effectively with subject matter experts
• Strong project management skills
• Ability to work effectively in a fast-paced, collaborative, and dynamic environment