Director, Evidence Generation

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.

Reporting to the Medical Director, Global Medical Affairs, the Associate Director of Evidence Generation will develop and execute evidence-generation plans, ensuring close alignment with product strategy. In close collaboration with Global Medical Affairs and cross-functional team members, this role will be responsible for driving the execution of a variety of evidence generation activities such as studies on natural history of disease, treatment trends, claims data, qualitative/quantitative research, and registries.

This role is based in the Lexington office and requires employees to be onsite five days a week.

Responsibilities (including, but not limited to):

• Engage with both internal and external stakeholders to perform evidence gap analyses that systematically and proactively identify key unanswered clinical and scientific questions
• Support the planning, design, and execution of evidence generation initiatives including conceptualization, document preparation, protocol reviews, and operational plans
• Manage timelines, deliverables, and budgets for all evidence generation initiatives
• Provide oversight of all evidence generation activity, including CRO-led activities (e.g., site trainings, data collection, data management)
• Translate evidence generation outputs into clear, concise, and targeted messaging and while maintaining medical accuracy and compliance
• Confidently present data to broad range of audiences, both in internal and external settings
• Drive appropriate collaboration with both internal and external stakeholders to assure evidence generation initiatives fit both corporate and product needs
• Closely collaborate with Scientific Communications to assure proper accurate, timely, and impactful dissemination of emerging evidence
• Proactively identify opportunities to improve evidence generation processes and efficiencies, including use of innovative tools and AI

Standout Skills for Success:

• Proactively identify opportunities for evidence generation
• Will clearly communicate complex data sets to various stakeholders
• Will review all datasets and final deliverables, assuring they are thorough, precise, and accurate
• Owns accuracy and timeliness of all deliverables

Qualifications:

• 10+ years of experience in related fields with a concentration in evidence generation
• Scientific degree (PhD, PharmD, MD) or relevant advanced science degree (MS, MPH)
• Direct experience in a pharmaceutical or CRO leading the planning and execution of a disease registry, preferably within rare disease space
• Strong attention to detail
• Ability to collaborate effectively with internal stakeholders and external stakeholders
• Excellent verbal and written communication skills, presentation skills, conflict management, and problem-solving skills are required
• Strong analytical skills and experience with clinical data presentation and interpretation
• Efficient independent worker with ability to focus and drive for results
• Ability to work in a fast paced-environment and to handle multiple tasks
• Strong commitment to compliance and ethical standards
• High proficiency in Microsoft Word, Excel, PowerPoint, CoPilot, and Outlook
• Experience with AI preferred
• Some travel may be required

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.