Associate Director of Clinical Science
Core
Support clinical development of radiopharmaceutical therapies for oncology indications by overseeing study design, protocol execution, data analysis, and regulatory document preparation.
Role type
Associate Director of Clinical Science (IC)
Builds
Clinical trial protocols, data analysis plans, regulatory filings (INDs, NDAs/MAAs), and scientific manuscripts.
Domain
Oncology / Radiopharmaceuticals / Clinical Development
Required skills
Clinical trial design, protocol development, data analysis, regulatory knowledge (FDA/EMA/ICH), cross-functional collaboration, scientific writing, data review, investigator relations
Preferred skills
PharmD or PhD, experience in biotech/pharmaceutical industry, ability to enter new therapeutic areas, AI tool usage
Technologies
SpotFire, Microsoft Office (Excel, PowerPoint)
Responsibilities
Develop study concept synopses and protocols, prepare study manuals and investigator meeting materials, review ongoing clinical data, organize Data Review Committee meetings, assist in preparation of regulatory documents (INDs, NDAs/MAAs), summarize scientific literature for new study development
Seniority
Senior, hands-on IC