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.
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
Your 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.
Qualifications and key experiences
- 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.
- Strong background in immunology‑focused biomarker assay development and clinical implementation.
- Experience working with clinical central laboratories, including coordination of sample logistics, assay execution, and data delivery for clinical studies.
- Hands‑on experience with bioanalytical platforms commonly used in immune disease research, such as (but not limited):
- Ligand‑binding assays (ELISA, MSD/ECL, other novel platforms)
- Multiplex cytokine and protein panels by various technology platforms
- Flow cytometry and immune cell phenotyping assays
- Cell‑based functional assays
- 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.
- Proven experience collaborating across multidisciplinary teams and managing external partners.
- Ability to thrive in a multi‑project, fast‑moving biotech environment.
- Strong attention the bioanalytical details for regulatory compliance.
- Strong written and verbal communication skills with the ability to clearly convey complex scientific and operational information.
Compensation decisions are based on objective criteria including role responsibilities, experience/qualifications, internal equity, geographic location, and external market benchmarks.
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.