Global Development Scientist, Senior Manager
Core
Translate disease strategy and target product profiles into study concepts, protocols, and key documents for early and late-phase trials in malignant haematology, immunotherapy, and cell therapy.
Role type
Senior Manager, Clinical Development Scientist
Builds
Clinical study protocols, plans, and regulatory submission content (NDA/BLA, IB, DSUR)
Domain
Biopharmaceuticals / Oncology (Haematology, Immunotherapy, Cell Therapy)
Required skills
Protocol design and writing, GCP/ICH/FDA regulatory knowledge, clinical data review and cleaning, stakeholder collaboration, site and investigator engagement, ethical and compliance leadership
Preferred skills
Malignant haematology clinical trial experience, immunotherapy and/or cell therapy trial experience, translational biomarkers and novel endpoints knowledge, global multicenter study experience, scientific publication record
Technologies
None stated
Responsibilities
Convert disease strategy into study concepts and protocols; ensure protocol alignment with GCP/ICH standards; provide scientific input for trial design and delivery; support clinical data review and report generation; develop content for global regulatory submissions; engage sites and investigators; maintain ethical and compliance standards
Seniority
Senior, hands-on IC with management responsibilities (via careerplan.io/jobs/R-257058-global-development-scientist-senior-manager-at-astrazeneca)