Senior Director, Clinical Translational Scientist

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

Senior Director, Clinical Translational Scientist

Lexington, MA

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.

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

• 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.

Compensation decisions are based on objective criteria including role responsibilities, experience/qualifications, internal equity, geographic location, and external market benchmarks.

Pay Range

$279,450 - $302,220 USD

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.