Director, Medical Writing

Regulatory Toolkit; Lexington (MA); On-site; USD 225,000 - 239,000; Full time

Job summary

Kiniksa Pharmaceuticals seeks a Director of Medical Writing to lead and mature the medical writing function across clinical development programs. Based in Lexington, MA, this role requires onsite presence five days a week and strategic contribution to high-quality, scientifically robust documents.

You will author and oversee CSRs, protocols, IBs, and program-level deliverables, translating complex data into compelling narratives while aligning messaging across teams.

Qualifications

• 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.

Responsibilities

• Lead the planning, authoring, and review of key clinical documents (CSRs, protocols, IBs).
• Translate complex data into clear, concise scientific narratives.
• Partner with Clinical Development, Clinical Operations, Biostatistics, and Safety to align documents.
• Drive process improvements and template/tool development for medical writing.

Skills

Scientific writing

Storytelling

Attention to detail

Stakeholder management

Autonomy

Education

Life sciences degree

Job description

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

StandoutSkills forImpact:

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 areprovidedreasonable accommodation toparticipatein 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.