Associate Director of Clinical Science

Associate Director of Clinical Science supports clinical development of radiopharmaceutical oncology therapies at RayzeBio, a Bristol Myers Squibb subsidiary. The role involves protocol development, clinical trial execution, data analysis, and regulatory document preparation in collaboration with cross-functional teams.

Responsibilities

• Develop study protocols, concept synopses, and amendments with guidance from medical writing and operations teams
• Design, review, and oversee clinical case report forms, data management documents, and analysis plans
• Organize and prepare materials for Data Review Committee meetings and investigator communications
• Prepare and review regulatory documents including INDs, DSURs, investigator brochures, and NDA/MAA submissions
• Analyze ongoing clinical data and contribute to manuscripts, presentations, and study result summaries

Requirements

• PharmD or PhD preferred; MS with 6+ years drug development experience
• BS in biological sciences with 8+ years relevant drug development experience
• Minimum 5 years clinical research or pharmacology in biotech/pharma or CRO
• Knowledge of FDA, EMA, and ICH regulations and guidelines
• Proficiency with Microsoft Office and analytical software such as SpotFire
• Strong cross-functional collaboration and communication skills
• Demonstrated adaptability and ability to learn quickly in new therapeutic areas

Compensation: Princeton, NJ: $173,217–$209,899; San Diego, CA: $190,539–$230,888