Senior Director, Clinical Translational Scientist

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.
• 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.

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 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.