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 (including, but not limited to):
Clinical & Medical Writing Leadership
- 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
Scientific Quality & Narrative Excellence
- 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
Cross-Functional Partnership
- Partner closely with Clinical Development, Clinical Operations, Biostatistics, and Safety to:
- Align early on document strategy and key messages
- Ensure consistency across program communications
- 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
Medical Writing Function Strategy & Excellence
- Contribute to the evolution of the medical writing function, aligned with the writing departments principles of:
- Working together: building strong partnerships and early alignment
- Doing it right: embedding quality into all deliverables
- 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
- Cross-program alignment of messaging
Process Improvement & Ways of Working
- 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
Standout Skills for Impact:
Key Competencies
- 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
This role directly contributes to
- Higher-quality documents with fewer review cycles
- Faster delivery timelines through better alignment and execution
- Clear, consistent clinical narratives across programs
- Enabling teams to focus on science while ensuring content is right, ready, and impactful
Qualifications and Experience:
- 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