Associate Global Development Scientist Director I
Core
Lead clinical development for late-phase oncology clinical programs, ensuring global study execution, data integrity, and regulatory submission support.
Role type
Senior IC clinical development scientist (oncology)
Builds
Clinical trial protocols, regulatory dossiers (IND/BLA), safety narratives, and clinical study reports
Domain
Pharmaceutical / Oncology
Required skills
Clinical trial design and conduct, Good Clinical Practice (GCP), regulatory approval processes, clinical data analysis, safety event review, manuscript preparation, cross-functional collaboration
Preferred skills
Oncology therapeutic area expertise, PharmD/PhD/MD, experience with CROs and vendors
Technologies
Clinical Research Forms (CRF), Clinical Study Reports (CSR), Investigator Brochures
Responsibilities
Support drafting and review of clinical scientific documents (IND, Annual Reports), assist in protocol implementation and investigator meeting materials, review clinical data for trends and outliers, participate in safety review meetings, support preparation of abstracts and manuscripts, assist with clinical report sections, support Data Management in CRF build
Seniority
Senior, hands-on IC