Director, Medical Writing
About The Position
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.
Requirements
- 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
- Thorough knowledge of drug development, ICH guidelines, Good Clinical Practice, CTD/eCTD organization, health authority expectations, and relevant pharmaceutical regulations
- Strong ability to synthesize and communicate complex data clearly
- Experience working in cross-functional clinical development teams
- Excellent communication, organization, and stakeholder management skills
Nice To Haves
- Exceptional scientific writing and storytelling ability
- High attention to detail with a focus on clarity and usability
- Ability to influence without authority and drive alignment
- Strong ownership mindset and ability to work autonomously
- Continuous improvement and solution-oriented thinking
Responsibilities
- Lead the planning, authoring, and review of key clinical documents, including: Clinical study reports (CSRs), Protocols and amendments, Investigator’s Brochures (IBs), 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, ensure consistency across program communications, and 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 departments principles of Working together, Doing it right, and Moving fast
- 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
Benefits
- Pay Range $225,000 - $239,000 USD
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What This Job Offers
Job Type
Full-time
Career Level
Senior
