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.

We are seeking a Senior Scientist/Manager, Clinical Bioanalysis to join our growing Research team in Lexington, MA. Reporting to the Executive Director, Bioanalytics, this individual will play a key role in the development and qualification of clinical pharmacology and translational biomarker assays and data analysis. This individual will be a key part of the team driving for successful clinical implementation of bioanalysis strategy in partnership with internal research, clinical development and operations and external clinical laboratories to support success of Kiniksa clinical development programs of innovative therapies for immune‑mediated diseases.

This is an exciting opportunity for a hands‑on scientist who enjoys working at the interface of immunology, translational and clinical development, and operations in a fast‑paced biopharmaceutical development environment.

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)

Collaborate with internal Research development, perform the late-stage development, qualification/validation, and implementation of translational and clinical biomarker assays supporting immune‑mediated disease programs.
Participate as a bioanalytical subject matter expert on cross‑functional project teams, working closely with internal early Research, Clinical Development and Operations, Clinical Pharmacology, Regulatory, Biostatistics.
Contribute as a SME to bioanalytical assays development strategy and execution for measuring target engagement, and pharmacodynamic responses (e.g., cytokines, chemokines, soluble receptors, immune cell markers) and more associated with the immune biology of the clinical studies.
Support DMPK bioanalysis activities, including PK, ADA, and PD biomarker integration, for biologics and novel therapeutic modalities.
Partner with clinical development, operations to provide SME support to central lab activities aligned with current regulatory guidance and industry best practices while remaining fit‑for‑purpose for each phase of development, including but not limited to activities such as:
Sample collection and handling strategies
Assay feasibility assessments and operational readiness
Method transfer, validation, and clinical sample testing
Data review, query resolution, and issue management
Collaborate with external CRO partnerships to ensure high‑quality, on‑time delivery of bioanalytical data.
Manage multiple bioanalytical projects simultaneously while maintaining scientific rigor, operational excellence, and timelines assigned to the role.

Standout Skills for Impact

Strong background in immunology‑focused biomarker assay development and clinical implementation.
Working knowledge of DMPK bioanalysis, including PK and ADA assessments.
Familiarity with regulatory expectations and industry best practices for bioanalytical assays and clinical laboratory operations.

Qualifications and Experience

MS or PhD in Analytical biochemistry, Cell biology, Immunology, or a related life science discipline. PhD in the related fields is preferred.
Requiring respective 4+ years for MS and 2+ years for PhD candidates direct industry experience in biotech, biopharmaceutical and/or CRO settings supporting translational and clinical bioanalysis.