Director, Translational Biomarker Lead, Inflammation/IBD

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Job Description

OBJECTIVES/PURPOSE

This position requires an acknowledged scientific and strategic leadership with managerial experience. The primary role is to provide scientific and strategic leadership in developing the translational biomarker strategy, and plans to secure implementation for Inflammatory diseases and IBD (Fibrostenotic CD), in the preclinical and clinical stages. This is a highly visible, strategic, and matrixed role, responsible for leading the Translational sub team (TST) partnering with Gastro-Intestinal & Inflammation drug discovery unit (GI2-DDU) research scientists, Gastro-Intestinal & Inflammation Therapeutic Area Unit (GI2-TAU) physician-scientists, clinical sciences, and relevant partner lines and functions to identify and validate biomarkers relevant to patients in clinical studies. Responsible for independently developing translational biomarker plans, aligned with functional leadership, as part of the overall Asset Strategy in the Discovery, Global Product Teams, and Medical sub-teams through all stages of discovery, clinical development, and post-market activities. Secure implementation and delivery of data and interpretation.

ACCOUNTABILITIES

• Partner with GI² DDU research scientists and GI² TAU physician-scientists in designing and executing Translational Research to discover and validate targeted pathways based on human data and define candidate biomarkers for mechanisms of action and drug response.
• Lead Translational Biomarker strategy development and execution to support the pre-clinical and clinical stage portfolio, including biomarker-driven clinical study design, implementation of novel technologies, and incorporation of biomarker endpoints for decision-making in early-stage clinical trials.
• Lead Translational subteam (TST) and provide matrix leadership and enhance collaboration across multiple functional areas, working closely with physician-scientists, clinical leads, clinical pharmacologists, BST, discovery research scientists, regulatory, non-clinical and other functions to build consensus for a fit-for-purpose biomarker strategy.
• Represent Translational and Biomarker Research on Project and Global Product Teams to provide pharmacodynamic, disease, and predictive biomarker strategies and support translational medicine goals of the assigned programs in all phases of clinical development.
• Contribute as a key member of the project teams that provide strategic, technical, and scientific leadership for the progression of the program from discovery research through development and contribute as a subject-matter expert for clinical development and overall asset strategies.
• Implement fit-for-purpose validation for all clinical biomarker assays with BST and ensure high scientific quality of target engagement/pharmacodynamics, prognostic and predictive biomarker data to drive program decision-making.
• Evaluate and utilize state-of-the-art scientific tools and ensure implementation of cutting-edge technology to drive innovation in the execution of biomarker strategy.
• Maintain extensive knowledge of the research and development efforts from academic institutions, competitor biopharmaceutical companies, and fee-for-service bioanalytical CROs for translational biomarker research.
• Responsible for the preparation and review of biomarker sections of candidate nomination, PRC documents,