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Associate Director, Translational Research and Biomarkers
Job Description
Remote Full time R12832
Job Summary:
We are seeking an experienced and highly motivated Translational Biomarker Scientist to support biomarker-driven drug development programs covering autoimmune and neurologic diseases. As a key member of cross-functional project teams, you will partner with Research, Preclinical, Clinical, Bioanalytical, Genomics, Regulatory, and Project teams to advance translational strategies, execute biomarker plans, and generate insights that inform critical clinical development decisions. This role provides the opportunity to drive innovative biomarker approaches and contribute to the development of novel therapies from early development through clinical proof of concept. Key Responsibilities
+ Serve as a core translational biomarker representative on cross-functional asset teams supporting clinical development programs.
+ Contribute to the development and execution of biomarker strategies, including target engagement/pharmacodynamic (TE/PD) biomarkers, patient stratification approaches, and mechanism-of-action hypotheses.
+ Support indication and patient population selection through integration of translational and clinical biomarker data.
+ Identify, select, and oversee biomarker assays in biological matrices, including management of outsourced activities and external laboratory partners.
+ Develop biomarker analysis plans and support the generation, review, and interpretation of clinical biomarker data for interim and final study analyses.
+ Collaborate with internal and external stakeholders to ensure biomarker activities are delivered on time and meet scientific, operational, and quality expectations.
+ Contribute to biomarker-related clinical study documents, regulatory submissions, and responses to health authority requests.
+ Evaluate and implement emerging technologies, digital biomarkers, and novel assay platforms that enhance biomarker measurement and clinical trial execution.
+ Present biomarker strategies, data, and recommendations to project teams and governance committees. Qualifications
+ PhD or MS in Immunology, Neuroscience, Molecular Biology, Genomics, Pharmacology, or a related scientific discipline.
+ Minimum of 5 years of relevant experience in translational medicine, biomarker sciences, clinical research, or clinical development within immunology and/or neurology.
+ Strong knowledge of biomarker discovery, validation, and application in clinical drug development.
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