Kiniksapharmaceuticals

Senior Director, Clinical Translational Scientist

Lexington, MA · Director

Sponsorship not specified$279k-$302kDetected 9 days ago

StatisticsPharmacologyFDA RegulatoryMolecular BiologyResearchExperimental DesignLeadershipBiostatisticsRegulatory Affairs

About the role

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.
The role requires deep expertise in translational medicine, biomarker strategy, immunology, and clinical drug development.

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.
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.
Maintain awareness of emerging scientific advances and competitive developments within immunology, inflammation, cardiovascular disease, and related therapeutic areas.
Contribute to departmental strategy, capability building, and organizational development.

12+ years of biotechnology or pharmaceutical industry experience, with significant experience in translational medicine and clinical drug development.
Working knowledge of biomarker development, clinical pharmacology, PK/PD relationships, and model-informed drug development.
Experience supporting regulatory interactions and submissions.

Advanced clinical development and translational medicine expertise strongly preferred.
Experience in immunology, inflammation, cardiovascular disease, rare disease, or related therapeutic areas preferred.

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.

Support interactions with health authorities related to biomarkers, companion diagnostics, and translational strategy.
Compensation decisions are based on objective criteria including role responsibilities, experience/qualifications, internal equity, geographic location, and external market benchmarks.
decisions are based on objective criteria including role responsibilities, experience/qualifications, internal equity, geographic location, and external market benchmarks.

This listing is sourced directly from Kiniksapharmaceuticals's careers page and normalized into a canonical job model.