Senior Director, Clinical Development

What You'll Do

Reporting to the VP of Clinical Development, the Senior Medical Director will provide medical leadership for clinical studies in chronic hypoparathyroidism. This individual will drive clinical strategy and execution across the development lifecycle, ensuring patient safety, scientific rigor, operational excellence, and successful regulatory interactions. The ideal candidate is a collaborative physician leader with rare disease experience and a passion for improving patient outcomes.

Responsibilities

·       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.

Where You'll Work

This is a San Francisco/Bay Area-based role that will require periodic travel for investigator meetings, site visits, regulatory meetings, and scientific congresses.

Who You Are

·       MD or equivalent medical degree required; board certification in Endocrinology, Nephrology, or a related specialty preferred.

·       5+ years of biotechnology, pharmaceutical, or clinical development experience with increasing medical leadership responsibilities.

·       Experience in rare disease, endocrinology, metabolic disease, or chronic hypoparathyroidism drug development strongly preferred.

·       Demonstrated expertise in clinical trial design, medical monitoring, protocol development, data interpretation, and regulatory interactions.

·       Strong understanding of ICH-GCP, FDA, EMA, and global regulatory requirements.

·       Exceptional communication, collaboration, and stakeholder management skills with the ability to influence across functions.

·       Patient-focused, intellectually curious, and motivated to thrive in a fast-paced, mission-driven biotechnology environment.