Director, Medical Writing — Clinical Narratives & Strategy

Kiniksa Pharmaceuticals; Lexington (MA); On-site; USD 225,000 - 239,000; Full time

Job summary

Kiniksa Pharmaceuticals in Lexington, MA seeks a Director, Medical Writing to lead and mentor as senior individual contributor, delivering high-quality clinical narratives for development programs. You will own strategy and authoring across CSRs, protocols, and summaries, enabling teams to move programs forward with clarity and impact.

You will collaborate with Clinical Development, Biostatistics, and Safety to ensure consistent messaging and efficient review cycles, while shaping the function's

Qualifications

• Degree in life sciences or related field.
• 8–12+ years of medical/clinical writing in biopharma or CRO.
• Ability to author 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.

Responsibilities

• Lead planning, authoring, and review of key clinical documents (CSRs, protocols, amendments).
• Translate complex data into clear, scientifically compelling narratives.
• Serve as writing expert within cross-functional teams.
• Drive document strategy alignment across programs and stakeholders.
• Support process improvements and templates to speed delivery.

Skills

Scientific writing

Storytelling

Attention to detail

Influence without authority

Ownership mindset

Cross-functional collaboration

Stakeholder management

Education

Life sciences degree

Job description

Kiniksa Pharmaceuticals in Lexington, MA seeks a Director, Medical Writing to lead and mentor as senior individual contributor, delivering high-quality clinical narratives for development programs. You will own strategy and authoring across CSRs, protocols, and summaries, enabling teams to move programs forward with clarity and impact.

You will collaborate with Clinical Development, Biostatistics, and Safety to ensure consistent messaging and efficient review cycles, while shaping the function's