• Provide medical expertise and leadership in the design and implementation of clinical development strategies aligned with company objectives. • Lead the development of clinical trial protocols, ensuring scientific rigor and compliance with global regulatory requirements. • Provide study leadership and collaborate with cross-functional team members across the lifecycle of the study (i.e., design, execution, interpretation, and communication). • Serve as medical monitor for clinical trials and to ensure adherence to ICH GCP, patient safety, and data integrity, in close collaboration with the CRO medical monitor. • Provide medical expertise for interactions with regulatory authorities, including required regulatory documentation and responses to questions from global regulatory agencies. • Build and maintain strong relationships with clinical investigators and thought leaders. • Effectively fosters productive and collegial working relationships in a cross-functional, matrix environment with internal and external stakeholders.