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.
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; 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 at scientific congresses; maintain awareness of emerging developments in chronic hypoparathyroidism, endocrinology, and rare disease drug development.
Who You Are (Qualifications)
- MD or equivalent medical degree required; board certification in Endocrinology, Nephrology, or related specialty preferred.
- 5+ years in biotechnology/pharmaceutical/clinical development with increasing medical leadership responsibilities.
- Experience in rare disease/endocrinology/metabolic disease/chronic hypoparathyroidism drug development strongly preferred.
- 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; patient-focused and motivated.
Where You'll Work
- San Francisco/Bay Area-based; periodic travel for meetings, site visits, regulatory meetings, and congresses.