Global Development Director Scientist
Core
Lead clinical strategy and protocol design for early and late-phase hematological cancer trials, ensuring scientific integrity and regulatory compliance for global product registration.
Role type
Senior IC clinical development director (hematology)
Builds
Clinical study protocols, clinical study reports, and regulatory submission documents for hematological oncology drugs.
Domain
Biopharmaceuticals / Hematology Oncology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical trial design and implementation, protocol writing and governance, clinical data review and interpretation, regulatory submission support (NDA/BLA), cross-functional leadership, GCP compliance
Preferred skills
PhD in scientific field, MD or PharmD, malignant haematology clinical trial experience, immunotherapy and cell therapy knowledge, FDA and international regulations expertise
Technologies
Clinical trial management systems, regulatory document generation tools
Responsibilities
Translate clinical strategy into study concepts and protocols, provide scientific input for trial delivery and data analysis, lead protocol development and clinical study reports, establish relationships with regulatory bodies and service providers, review medical and clinical trial data with Medical Director, support regulatory submission documents, train investigators
Seniority
Senior, hands-on IC with strategic oversight
