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Global Development Scientist Associate Director Haematology

AstraZeneca GmbH

Job Title: Global Development Associate Director Scientist

Introduction to role

This role is based in Barcelona, with an on-site commitment of three days a week. Fluency in English is required.

Are you ready to turn breakthrough science in hematologic cancers into decisive clinical evidence that reaches patients worldwide? Can you translate clinical strategy into robust protocols that accelerate combinations and novel mechanisms toward registration? In this role, you will be a key clinical leader within a high-ambition oncology organization focused on improving outcomes for people with blood cancers.

You will drive studies from concept through reporting and global submissions, shaping decisions that determine how and when our medicines reach patients. Working at the intersection of science, medicine and execution, you will join colleagues who blend academic rigor with industry pace to advance a diverse, combination-led pipeline. You will lead with purpose—bringing scientific depth, operational clarity and cross-functional influence—so our trials ask the right questions, run efficiently, and generate clean, interpretable data that inform regulatory and clinical practice.

Accountabilities

Work cross functionally within CPT to ensure the clinical strategy is translated into the development of the study concept document, study protocol and related documents

Provide clinical/scientific input into design & implementation of clinical trial(s), their delivery, clinical data review and data cleaning, interpretation of results, reporting successfully on time, and activities required for worldwide registration of the product (i.e. clinical input to NDA/BLA).

Establish key relationships internally with clinical project teams, and externally with regulatory bodies and external service providers.

Accountable for the relevance and accuracy of clinical science underpinning of clinical study based on detailed scientific review and consultation, for the clinical and scientific leadership and integrity of protocols and/or components of clinical plans and for the delivery of final protocol and its governance approval.

Lead the development of the protocol and related documents and the development and delivery of the clinical study report to meet GCP, ICH and all AstraZeneca quality standards.

Lead cross functional projects to ensure the successful passage of drugs through all phases of the drug development process, or contribute to one or more elements of such a project as a technical expert.

Review and interpret medical data and clinical trial data and come up with conclusions with Medical Director

You will support the development of clinical components of regulatory and EC/IRB submission documents for instances where marketing approval is warranted. Prepare and provide input to clinical study reports (CSRs) and clinical portions of Regulatory Documents (e.g., IB, DSUR, PSUR, regulatory responses)

Participate or lead as needed the review and assessment of new opportunities and ESRs.

Responsible for timely responses to investigational study sites for local ICF changes, protocol & EC/IRB questions/requests.

Contribute to development and delivery of face to face or virtual investigator and supervise training.

Essential Skills/Experience

BS required.

Minimum of 3 years of relevant experience.

Industry or Academic experience in drug development required with experience in malignant haematology clinical trials strongly preferred.

Sufficient technical knowledge (haemato-oncology background preferred) to be able to interact with confidence with internal and external partner.

Possesses sound foundational knowledge of FDA and other major country regulations and detailed knowledge of Good Clinical Practice other regulations governing clinical research.

Ability to drive/contribute to protocol design, writing and implementation.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

#J-18808-Ljbffr

Oferta de empleo publicada 4 días atrás
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