Medical Monitor - Clinical Development

Job Summary

Reporting to the VP Clinical Development, the full-time remote Director - Clinical Development (Medical Monitoring) will manage clinical trial execution, serve as a medical monitor, and provide clinical guidance while collaborating with internal and external stakeholders.

Key responsibilities

• Serve as Medical Monitor for assigned clinical trials, reviewing emerging medical/safety data and collaborating with external CRO partners
• Play an active role in planning, conducting, and evaluating ongoing clinical trials to ensure successful execution
• Contribute to the preparation and critical review of regulatory documents and scientific data disclosures

Required qualifications

• Board Certified MD or MD/PhD or equivalent qualification with relevant medical experience, preferably in hepatology or internal medicine
• Minimum of 3 years of relevant experience in clinical development within the biotech or pharmaceutical industry
• Direct experience in executing and medical monitoring of clinical trials, particularly Phase 3 trials
• Solid knowledge of GCP, ICH guidelines, and FDA/EMA/CHMP regulations
• Experience with preparation of documentation for BLA/NDA/MAA submissions is desirable