Global Development Director Scientist
Core
Lead clinical strategy and scientific input for early and late-phase hematological cancer drug development programs, ensuring protocol design, data review, and regulatory submission readiness.
Role type
Senior Director, Clinical Development Scientist (Hematology)
Builds
Clinical study protocols, clinical study reports, regulatory documents (NDA/BLA), and global clinical strategies for hematological oncology assets.
Domain
Biopharmaceuticals / Hematology Oncology / Clinical Development
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical trial design and implementation, medical data interpretation, regulatory strategy (FDA/ICH/GCP), cross-functional leadership, protocol governance, stakeholder management, training delivery
Preferred skills
PhD in scientific field, MD or PharmD, malignant haematology clinical trial experience, immunotherapy and cell therapy expertise, deep knowledge of FDA and international regulations
Technologies
GCP, ICH guidelines, NDA/BLA submission frameworks, clinical data management systems
Responsibilities
Translate clinical strategy into study concepts and protocols; review and interpret clinical trial data with Medical Directors; lead development of clinical study reports and regulatory documents; establish relationships with regulatory bodies and external providers; train investigators and site personnel; ensure compliance with GCP and local regulations.
Seniority
Director, strategic leadership with hands-on scientific execution