Director, Medical Writing

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

Additional information

Compensation decisions are based on objective criteria including role responsibilities, experience/qualifications, internal equity, geographic location, and external market benchmarks.

Pay Range $225,000—$239,000 USD

Kiniksa does not accept unsolicited resumes from staffing agencies or search firms. Any resumes submitted without a signed agreement will be considered property of Kiniksa, and no fees will be paid.