Overview
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In this role, you drive the clinical development strategy for AstraZeneca’s hematology programs, collaborating across integral teams to shape study concepts, protocols, and regulatory submissions. You will provide scientific input on trial design, data interpretation, and reporting to support worldwide product registration. The role blends scientific leadership with cross-functional program delivery in immunotherapy and cell therapy. You will influence external stakeholders and uphold GCP and regulatory standards while advancing life-changing medicines.
Responsabilidades
Translate clinical strategy into study concepts and protocols across CPT
Provide scientific input for trial design and delivery, including immunotherapy and cell therapy studies
Establish internal and external relationships with clinical teams, regulators, and external service providers
Ensure clinical science underpinning protocols and plans is accurate and governed by quality standards
Lead protocol development and delivery of the clinical study report to meet GCP and ICH standards
Drive cross-functional projects to advance drugs through all development phases or contribute as a technical expert




Review and interpret medical and trial data to inform conclusions with Medical Director
Support development of regulatory and EC/IRB submission components for marketing approval
Participate in review/assessment of new opportunities and ESRs
Coordinate timely responses to investigational site questions and changes
Contribute to investigator training and supervision of site activities
Requisitos principales
BS required; PhD, PharmD, or MD strongly preferred
Minimum 5 years of relevant experience
Industry or academic drug development experience; hematology/haematology oncology experience strongly preferred xqbhyrx
Ability to interact confidently with internal and external partners
Foundational knowledge of FDA and major country regulations and GCP
Knowledge of medical monitoring, regulatory approvals, pharmaceutical R&D; operations, and market fundamentals
Proven ability to drive protocol design, writing, and implementation
Experience with translating clinical data into regulatory submissions
strong collaborative communication
influencing diverse stakeholders
cross-functional teamwork
clinical trial design and execution
data review and data cleaning
regulatory submissions (NDA/BLA)

📌 Global Development Director Scientist (Barcelona)
🏢 AstraZeneca
📍 Barcelona