Associate Director of Clinical Science
$173.22k - $209.9kBristol Myers Squibb
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
Vacancy posted 2 days ago
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