Global Development Scientist Director, Hematology R&D

AstraZeneca; Barcelona; Híbrido; EUR 120.000 - 160.000; Jornada completa

Descripción de la vacante

AstraZeneca in Barcelona, hybrid 3 days in the office and 2 days remote, seeks a Global Development Scientist Director to lead early and late hematology development programs. You will guide study concepts, protocol development and cross-functional collaboration with CPT & GST, SMM, and regulatory bodies to ensure timely, high-quality regulatory submissions.

You will provide scientific input, oversee clinical trial execution, data review, and write robust CSRs while maintaining GCP compliance and

Formación

• BS required; PhD in a scientific field strongly preferred.
• Minimum of 5 years of relevant experience.
• Industry or Academic experience in drug development.
• Haematology/haemato-oncology background recommended.
• Knowledge of FDA and major country regulations; GCP familiarity.
• Ability to drive protocol design and implementation.

Responsabilidades

• Translate clinical strategy into the development of study concepts and documents.
• Provide input into the design and implementation of clinical trials; CNS/EIT scope included.
• Build key internal and regulatory relationships; interact with external partners.
• Ensure clinical science underpinning protocols and related components.
• Lead protocol development and delivery of clinical study reports.
• Lead cross-functional projects through drug development phases.
• Review medical data with the Medical Director and draw conclusions.
• Support regulatory submissions with CSRs and regulatory documents.
• Participate in review of new opportunities and ESRs.
• Respond to investigational site queries and EC/IRB questions.
• Contribute to investigator training and site education.

Conocimientos

Clinical development

Cross-functional leadership

Haematology

Regulatory knowledge

GCP compliance

Protocol design

Medical writing

Educación

BS degree required

PhD in scientific field preferred

PharmD or MD preferred

Descripción del empleo

AstraZeneca in Barcelona, hybrid 3 days in the office and 2 days remote, seeks a Global Development Scientist Director to lead early and late hematology development programs. You will guide study concepts, protocol development and cross-functional collaboration with CPT & GST, SMM, and regulatory bodies to ensure timely, high-quality regulatory submissions.

You will provide scientific input, oversee clinical trial execution, data review, and write robust CSRs while maintaining GCP compliance and