· Serve as the medical lead for one or more clinical programs, providing strategic and operational leadership across study design, execution, analysis, and reporting.
· Lead cross-functional clinical study teams and provide medical oversight to ensure participant safety, data quality, protocol compliance, and study interpretability.
· Partner with investigators, key opinion leaders, advocacy organizations, and CRO partners to execute high-quality clinical trials.
· Author and review protocols, investigator brochures, clinical study reports, DSURs, informed consent documents, and regulatory submission content.
· Lead medical monitoring activities and contribute to safety review meetings, investigator meetings, and regulatory authority interactions.
· Translate clinical, translational, and nonclinical findings into actionable development strategies and lifecycle plans.
· Represent Calcilytix at scientific congresses and maintain awareness of emerging developments in chronic hypoparathyroidism, endocrinology, and rare disease drug development.