Associate Global Development Scientist Director I
Core
Lead pivotal clinical trials and AI-enabled development for late-phase oncology programs, ensuring worldwide product registration.
Role type
Senior IC clinical development scientist (oncology)
Builds
Clinical trial protocols, registration dossiers (NDA/BLA), safety narratives, and scientific publications
Domain
Pharmaceutical / Oncology
Required skills
Clinical trial design and conduct, Good Clinical Practice (GCP), regulatory approval processes, medical monitoring, data analysis, scientific writing
Preferred skills
Oncology therapeutic area expertise, PharmD/PhD/MD, industry or academic drug development experience
Technologies
Clinical trial management systems, statistical analysis tools
Responsibilities
Draft and review clinical scientific documents (IND, Investigator Brochures, Annual Reports), implement protocols and interact with vendors/CROs, review clinical data for trends and outliers, participate in safety review meetings, support preparation of abstracts and manuscripts, assist with drafting clinical reports and dossiers, support Data Management in CRF build
Seniority
Senior, hands-on IC