Director, Medical Writing

About the role

Kiniksa Pharmaceuticals is seeking a highly experienced Director, Medical Writing to serve as a senior individual contributor supporting clinical development programs through clear, high-quality, and scientifically robust medical writing. This role is central to delivering clinical narratives that are accurate, aligned, and impactful, enabling teams to make informed decisions and advance programs efficiently. In addition to leading document development, the Director will contribute to the evolution of the medical writing function’s strategy, helping drive quality, speed, and consistency across the portfolio. This role is based in our Lexington, MA office and requires employees to be onsite five days per week.

Responsibilities

• Lead the planning, authoring, and review of key clinical documents, including clinical study reports (CSRs), protocols and amendments, investigator’s brochures (IBs), and clinical summaries and other program-level deliverables.
• Translate complex clinical and statistical data into clear, concise, and scientifically compelling narratives.
• Serve as a trusted writing expert within cross-functional teams.
• Ensure all documents meet the highest standards for clarity, accuracy, consistency, and interpretability.
• Drive alignment of clinical messaging and data interpretation across documents and stakeholders.
• Minimize rework through thoughtful structuring, early alignment, and strong storytelling.
• Partner closely with Clinical Development, Clinical Operations, Biostatistics, and Safety to align early on document strategy and key messages.
• Partner closely with Clinical Development, Clinical Operations, Biostatistics, and Safety to ensure consistency across program communications.
• Partner closely with Clinical Development, Clinical Operations, Biostatistics, and Safety to facilitate efficient review cycles and timely delivery.
• Act as a bridge between data and communication, enabling teams to focus on science while ensuring content excellence.
• Contribute to the evolution of the medical writing function, aligned with the writing department’s principles of working together (building strong partnerships and early alignment), doing it right (embedding quality into all deliverables), and moving fast (enabling efficient, timely document delivery).
• Support development and refinement of templates, tools, and best practices.
• Help drive initiatives that improve document quality and consistency, speed and efficiency of delivery, and cross-program alignment of messaging.
• Identify opportunities to simplify processes and reduce review burden.
• Contribute to a culture of clear ownership, accountability, and continuous improvement.
• Provide guidance to peers and external partners to elevate overall writing capability.

Qualifications

• Degree in life sciences or related field.
• 8–12+ years of experience in medical/clinical writing in biopharma or CRO.
• Demonstrated expertise in authoring complex clinical documents independently.