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Jobtailor in the United States is seeking a physician-scientist with an MD or MD/PhD to lead early clinical development in neuro-psychiatric targets and biomarker strategies.
You will design and oversee translational studies across preclinical and Phase I–II trials, collaborating with discovery sciences, pharmacology, regulatory affairs, and global trials teams to drive regulatory filing support and cross-functional development initiatives.
• Work with basic science teams on specific diseases and therapeutic areas, providing clinical expertise for identification and validation of novel targets
• Design preclinical and clinical experiments to validate targets and/or pathways and leverage this work for development of novel therapeutics
• Collaborate with discovery scientists, pharmacologists, toxicologists, and other specialists to advance therapeutics from preclinical into clinical development
• Lead early development teams and collaborate with internal and external staff across discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs, and global clinical trials operations
• Develop and execute clinical pharmacology studies in Phases I–IV, including formulation or device changes, drug-drug interaction studies, and special-population studies
• Provide early-phase and clinical pharmacology support through regulatory filing, including preparation of supporting documents and presentations
• Develop and execute studies to validate clinical biomarkers using blood/tissue sampling, imaging, electrophysiological methods, wearable devices, and behavioral responses
• Assess internal and external partnership opportunities using clinical and scientific expertise
• Engage with scientific and academic thought leaders through consultations, posters, publications, and conference attendance/presentations
• Work with key functions across the company at research sites around the world
• Contribute to novel target identification and validation with Discovery Sciences
• Lead early clinical development strategy from preclinical development through Phase 1 and Phase 2 proof-of-concept studies
• Develop biomarker strategies and experimental medicine studies from First-in-Human studies through clinical Proof-of-Concept
• Develop and execute clinical pharmacology strategies supporting later development and worldwide regulatory applications
Demonstrates expertise in clinical pharmacology and early clinical development, with a focus on designing and executing studies that validate novel therapeutic targets and biomarkers. Engages effectively with cross-functional teams and thought leaders to advance drug development from preclinical to clinical phases.