Senior Director, Translational Medicine Immunology
4 weeks ago
The Company:
Do you have the right skills and experience for this role Read on to find out, and make your application.This organization is a mid-sized pharmaceutical company with a diverse pipeline of small molecules and biologics across a variety of disease areas including immunology, neuroscience and oncology. It's an incredibly exciting time as they continue to invest heavily in expanding R&D capabilities across the US which includes assessing the landscape from promising assets to acquire, develop and bring to market.
The Role:
- Develop and manage execution of the overarching translational strategy for the Immunology portfolio in alignment with company goals
- Lead matrix team of Translational Science, Clinical Biomarker, and Physicians; ensuring regular portfolio reviews, proactively identifies issues, obstacles, and challenges, and develops contingency plans.
- Oversees generation and evaluation of scientific and clinical insights that contribute to the characterization of the drug target, guide indication selection, identify targeted patient populations, support rational drug combinations, and inform mechanisms of action and resistance.
- Manages biomarker development and research initiatives, including association of molecular, histologic, radiographic, physiologic, and digital biomarkers with drug response, safety and/or compliance.
- Oversees identification and validation of novel endpoints for early decision making and patient or target population stratification strategies to support rapid demonstration of safety and efficacy
- Oversees design of experiments and studies, analysis and interpretation of data, writing of study reports, summary of key findings, and communication of insights and recommendations to the Immunology TA leadership and relevant R&D functions.
- Leads regulatory engagements and submissions, interacting with regulatory inspectors and auditors.
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