Lead Translational Medicine & Biomarker Strategy

Kiniksa Pharmaceuticals; Lexington (MA); On-site; USD 279,450 - 302,220; Full time

Job summary

Kiniksa Pharmaceuticals is seeking a Senior Director, Clinical Translational Scientist to lead translational medicine across clinical programs in Lexington, MA. This role integrates disease biology, biomarkers, pharmacology, and clinical outcomes to inform data-driven development decisions.

The leader will drive biomarker strategies, collaborate across Research, Clinical Development, Regulatory Affairs, and Medical Affairs, and contribute to INDs and regulatory submissions.

Qualifications

• 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 translational medicine and clinical drug development experience.
• Experience supporting regulatory interactions and submissions.

Responsibilities

• Lead development and execution of integrated translational medicine strategies across clinical development programs.
• Develop and refine biomarker and clinical pharmacology plans to support target engagement and dose optimization.
• Translate emerging data into actionable development recommendations.
• Identify translational milestones to inform portfolio decisions and stage-gate transitions.
• Define biomarker strategies across exploratory, pharmacodynamic, predictive, prognostic, and diagnostic biomarkers.
• Partner with bioanalytical and laboratory teams to develop and implement biomarker assays.
• Lead interpretation of biomarker, PK/PD, and clinical datasets to generate insights.
• Support implementation of innovative translational approaches.
• Contribute to study design, endpoint selection, and clinical study execution.
• Build relationships with internal and external stakeholders including CROs and KOLs.
• Contribute translational components to regulatory submissions including INDs and marketing applications.
• Support interactions with health authorities related to biomarkers and translational strategy.
• Maintain awareness of advances in immunology, inflammation, cardiovascular disease, and related areas.
• Foster a collaborative, patient-focused, and scientifically rigorous culture.
• Contribute to departmental strategy and organizational development.

Skills

Translational medicine

Biomarker strategy

Cross-functional leadership

Clinical drug development

Immunology expertise

Education

PhD/MD/PharmD

Tools

Biomarker assays

Job description

Kiniksa Pharmaceuticals is seeking a Senior Director, Clinical Translational Scientist to lead translational medicine across clinical programs in Lexington, MA. This role integrates disease biology, biomarkers, pharmacology, and clinical outcomes to inform data-driven development decisions.

The leader will drive biomarker strategies, collaborate across Research, Clinical Development, Regulatory Affairs, and Medical Affairs, and contribute to INDs and regulatory submissions.