Global Development Scientist, Director
Core
Lead global hematology clinical trials to generate evidence for transforming cancer therapies from hypothesis to registration.
Role type
Director-level clinical development scientist (hematology/oncology)
Builds
Clinical study protocols, pivotal trial data, and regulatory submission packages for immuno-oncology and cell therapy assets.
Domain
Biopharmaceuticals / Oncology / Hematology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical strategy translation, protocol design and governance, trial delivery leadership, data integrity and interpretation, regulatory evidence preparation, stakeholder collaboration, site and investigator engagement, cross-program leadership
Preferred skills
NDA/BLA submission experience, immunotherapy and cell therapy trial design, cross-functional initiative leadership, external service provider oversight, investigator meeting planning
Technologies
GCP, ICH guidelines, FDA regulations, Investigator's Brochure, DSUR, PSUR
Responsibilities
Convert disease strategy into study concepts and protocols; provide clinical/scientific leadership for pivotal protocols; lead clinical data review and synthesis for go/no-go decisions; prepare clinical content for global regulatory submissions; engage with investigational sites and regulatory bodies; drive cross-asset process improvements.
Seniority
Director, strategic leadership with hands-on scientific oversight
