Head Of Clinical Bioanalysis Jobs (NOW HIRING)

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 immunemediated diseases.

This is an exciting opportunity for a handson scientist who enjoys working at the interface of immunology, translational and clinical development, and operations in a fastpaced 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 immunemediated disease programs.
• Participate as a bioanalytical subject matter expert on crossfunctional 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 fitforpurpose 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 highquality, ontime 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 immunologyfocused 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.
• Experience working with clinical central laboratories, including coordination of sample logistics, assay execution, and data delivery for clinical studies.
• Handson experience with bioanalytical platforms commonly used in immune disease research, such as (but not limited):
• Ligandbinding assays (ELISA, MSD/ECL, other novel platforms)
• Multiplex cytokine and protein panels by various technology platforms
• Flow cytometry and immune cell phenotyping assays
• Cellbased functional assays
• Proven experience collaborating across multidisciplinary teams and managing external partners.
• Ability to thrive in a multiproject, fastmoving 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.