Overview

In this role, you drive the clinical development strategy for AstraZeneca’s hematology programs, collaborating across general 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 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