Senior Director, Clinical Translational Scientist
About The Position
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.
Requirements
- PhD, PharmD, MD, or MD/PhD in Immunology, Translational Medicine, Pharmacology, Molecular Biology, Clinical Science, or related discipline.
- 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.
- Working knowledge of biomarker development, clinical pharmacology, PK/PD relationships, and model-informed drug development.
- Experience supporting regulatory interactions and submissions.
Nice To Haves
- Advanced clinical development and translational medicine expertise strongly preferred.
- Experience in immunology, inflammation, cardiovascular disease, rare disease, or related therapeutic areas preferred.
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.
Benefits
- 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.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Ph.D. or professional degree
