Associate Director of Clinical Science

Role: Associate Director of Clinical Science supporting clinical development of RayzeBio's radiopharmaceuticals for oncology indications. Responsibilities: collaborate on study design, develop and review protocols, CRFs, Data Management Plans, and regulatory documents; oversee data analysis and review clinical data; support NDA/MAA preparation; coordinate clinical trial activities from start-up to closeout; lead scientific communication and troubleshooting; leverage AI tools to enhance productivity. Requirements: PharmD or PhD preferred; 6+ years with MS, or 8+ years with BS in biological sciences, with at least 5 years in clinical research or pharmacology within biotech or CRO; strong knowledge of FDA, EMA, ICH regulations; proficient in Microsoft Office and data analytics tools like SpotFire. HighValue: experience in oncology, radiopharmaceuticals, early to late-stage development, and regulatory submissions; ability to work cross-functionally across clinical, medical, and regulatory teams; travel up to 20%. WorkSetup: hybrid with up to 20% travel.