• Design scientifically rigorous, innovative, and cost-effective clinical development programs, integrating preclinical, translational, and biomarker strategies • Direct and oversee the efficient implementation of all clinical projects, including defining initial clinical endpoints, dose-escalation strategies, and patient selection approaches • Lead development and contribute to review of Clinical Study Protocols, Clinical Study Reports, Investigator’s Brochures, and all clinical documentation for regulatory filings • Become an internal expert on all medical features of the disease area, including natural history, patient diagnostic journey, standards of care, and current development programs. • Build, mentor, and scale the clinical development and clinical operations teams, including defining structure, capabilities, and external partnerships appropriate for each stage of the program • Provide leadership and clinical development expertise to the overall organization, including the clinical development, clinical operations, biometrics, toxicology, and translational science teams • Collaborate with Regulatory Affairs to develop strategies and tactical work plans during clinical development and in preparation for the anticipated US and global filings • Lead the preparation and management of clinical information to support timely regulatory submissions, including INDs, briefing documents, and early clinical protocols • Set a high standard and example of urgency, work quality, and effectiveness • Contribute to due diligence and gap analysis on potential new GondolaBio assets • Partner closely with discovery and preclinical teams to ensure clinical readiness for first-in-human studies. • Perform all other duties as assigned