Senior Director, Clinical Translational Scientist

Kiniksa is seeking an accomplished and strategic Senior Director, Clinical Translational Scientist reporting to GVP, Research & Non-Clinical Development to play a critical leadership role in advancing clinical-stage development programs from early clinical development through proof-of-concept and registrational studies. The successful candidate will drive translational strategies that connect disease biology, mechanism of action, biomarkers, pharmacology, and clinical outcomes to enable data-driven development decisions.

This individual will serve as a key scientific leader across multidisciplinary teams, integrating insights from Research, Clinical Development, Clinical Pharmacology, Bioanalysis, Biostatistics, Regulatory Affairs, and Medical Affairs to maximize the probability of technical and regulatory success across the portfolio. The role requires deep expertise in translational medicine, biomarker strategy, immunology, and clinical drug development.

This role is based in our Lexington, MA office. Our office-based employees follow an onsite schedule of 5 days in the office (Mon-Fri)

Responsibilities (including, but not limited to):

• Lead development and execution of integrated translational medicine strategies across clinical development programs.
• Develop and continually refine biomarker and clinical pharmacology plans to support target engagement, proof-of-mechanism, proof-of-biology, dose optimization, and patient selection.
• Translate emerging biological, pharmacological, and clinical data into actionable development recommendations.
• Identify and prioritize translational milestones to inform key portfolio decisions and stage-gate transitions.
• Define biomarker strategies spanning exploratory, pharmacodynamic, predictive, prognostic, and diagnostic biomarkers.
• Partner with bioanalytical and laboratory teams to develop, validate, and implement clinical biomarker assays.
• Lead interpretation of biomarker, PK/PD, and clinical datasets to generate insights regarding mechanism of action, treatment response, and resistance pathways.
• Support implementation of innovative technologies and emerging translational approaches.
• Contribute to study design, protocol development, endpoint selection, statistical analysis planning, and clinical study execution.
• Build productive relationships with internal stakeholders, external partners, CROs, academic investigators, key opinion leaders, and laboratory vendors.
• Contribute translational components to regulatory submissions including INDs, briefing documents, and marketing applications.
• Support interactions with health authorities related to biomarkers, companion diagnostics, and translational strategy.
• Maintain awareness of emerging scientific advances and competitive developments within immunology, inflammation, cardiovascular disease, and related therapeutic areas.
• Foster a collaborative, patient-focused, and scientifically rigorous culture.
• Contribute to departmental strategy, capability building, and organizational development.

Standout Skills for Impact:

• Expertise in developing and executing translational medicine and biomarker strategies across clinical development programs.
• Proven ability to integrate scientific, biomarker, and clinical data to deepen the understanding of patient populations and drug mechanism of action in patients.
• Experience leading and influencing cross-functional teams across Research, Clinical Development, Regulatory Affairs, and Medical Affairs.
• Demonstrated success supporting programs from early clinical development through proof-of-concept and late-stage studies.

Qualifications and Experience:

• PhD, PharmD, MD, or MD/PhD in Immunology, Translational Medicine, Pharmacology, Molecular Biology, Clinical Science, or related discipline.
• Advanced clinical development and translational medicine expertise strongly preferred.
• 12+ years of biotechnology or pharmaceutical industry experience, with significant experience in translational medicine and clinical drug development.
• Demonstrated success supporting programs from IND through proof-of-concept and/or late-stage clinical development.
• Experience in immunology, inflammation, cardiovascular disease, rare disease, or related therapeutic areas preferred.
• Working knowledge of biomarker development, clinical pharmacology, PK/PD relationships, and model-informed drug development.
• Experience supporting regulatory interactions and submissions.