Director, Medical Writing

Kiniksa Pharmaceuticals is a commercial‑stage biopharmaceutical company developing and commercializing novel therapies for diseases with unmet need, with a focus on cardiovascular indications. With deep expertise in immunology and inflammation, Kiniksa is advancing a growing portfolio of approved and investigational medicines, anchored by its lead product, ARCALYST®, the first and only FDA‑approved therapy for recurrent pericarditis. Grounded in rigorous science and bold innovation, the company fosters a highly collaborative, patient‑first culture led by accomplished life sciences leaders. At Kiniksa, talented individuals are trusted and empowered to make a real impact—shaping the future of medicine while improving the lives of patients who need it most.

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

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 is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, transgender status, age, genetics, national origin, protected veteran status, or disability status, or any other legally protected category. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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.