Global Development Director Scientist - Hematology

About the role

AstraZeneca's Hematology Research and Development unit, covering early and late development, is looking for a Global Development Director Scientist in Barcelona. The role sits in the Clinical Project Team (CPT) and Global Study Team (GST) in a matrix environment, working with Site Management and Monitoring, field liaisons and site personnel. It works closely with the Global Development Medical Director on the clinical aspects of products, and shares responsibility with Clinical Operations for planning and delivering clinical studies. The position is based in Barcelona with 3 days in the office and 2 days working from home.

Key responsibilities

• Translate the clinical strategy into the study concept document, protocol and related documents, and lead the development of the protocol and the clinical study report to meet GCP, ICH and AstraZeneca quality standards.
• Provide clinical and scientific input into the design and implementation of clinical trials, including those involving immunotherapy and cell therapy, data review, cleaning, result interpretation and worldwide registration (NDA/BLA).
• Build relationships with clinical project teams, regulatory bodies and external service providers, and respond in time to site requests on local ICF changes and protocol questions.
• Review and interpret medical and clinical trial data with the Medical Director, and support clinical parts of regulatory and ethics submission documents (IB, DSUR, PSUR, regulatory responses).
• Lead cross-functional projects to move drugs through all phases of development, or contribute as a technical expert, and help develop investigator and supervisee training.

Required profile

• BS required; PhD in a scientific field, PharmD or MD strongly preferred.
• At least 5 years of relevant experience.
• Industry or academic experience in drug development, with experience in malignant haematology clinical trials strongly preferred.
• Ability to communicate with and influence a wide range of internal and external stakeholders, and to follow ethical standards, internal SOPs, local regulations and Good Clinical Practice.

Required skills

• Sufficient technical knowledge (haemato-oncology background preferred) to work confidently with partners.
• Foundational knowledge of FDA and other major country regulations, and detailed knowledge of Good Clinical Practice.
• Knowledge of medical monitoring, regulatory approval processes, pharmaceutical R&D operations and marketing fundamentals.
• Track record of completing and leading protocol design, writing and implementation, and of delivering clinical study plans and documents.