Director, Clinical Development - Hybrid, SF

Assembly Biosciences, Inc.; South San Francisco (CA); Hybrid; USD 289,000 - 313,000; Full time

Job summary

Assembly Bio is seeking a Director of Clinical Development in South San Francisco, hybrid role. The position leads clinical study strategy, protocol development, and execution, interfacing with regulators and ethics committees. This is a senior MD role that acts as lead medical monitor for company-sponsored studies.

You will oversee safety reviews, data interpretation, and regulatory filings while mentoring clinical teams and coordinating with external CROs to ensure timely study delivery.

Qualifications

• MD (or DO) is required.
• Minimum of 5 years in clinical development in biotech/pharma/CRO setting.
• Experience as a medical monitor or in safety review of trials is required.

Responsibilities

• Design and execute clinical development plans and protocols for viral diseases and other indications.
• Serve as medical monitor for company-sponsored trials, provide real-time medical oversight to investigators and sites.
• Develop and maintain study-level Medical Monitoring Plans and oversee CRO medical monitors.
• Review safety data and laboratory results; partner with Drug Safety for SAE/SUSAR assessments.

Skills

MD/DO

Medical monitoring

Clinical trial oversight

GCP knowledge

Regulatory interactions

Education

MD or DO degree

Job description

Assembly Bio is seeking a Director of Clinical Development in South San Francisco, hybrid role. The position leads clinical study strategy, protocol development, and execution, interfacing with regulators and ethics committees. This is a senior MD role that acts as lead medical monitor for company-sponsored studies.

You will oversee safety reviews, data interpretation, and regulatory filings while mentoring clinical teams and coordinating with external CROs to ensure timely study delivery.