Global Development Associate Director Scientist, Haematology R&D

Role Barcelona onsite - 3 days office/ 2 days home.

Join our Hematology R&D team at AstraZeneca where we are committed to advancing the science to deliver life-changing medicines to patients most in need. Our focus is on a combination-focused pipeline that exploits the power of six scientific platforms to help address unmet clinical needs in a host of hematological cancers. We are motivated by a dedication to the scientific discovery and collaboration that will one day helpeliminatecancer as a cause of death.

Main duties:

• Work cross functionally within CPT to ensure the clinical strategy is translated into the development of the study concept document studyprotocoland 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 activitiesfor 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 developmentprocess orcontribute to one or more elements of such a project as a technical expert.

• Review and interpret medical data and clinical trial data andcome up withconclusions with Medical Director

• You will support the development of clinical components of regulatory and EC/IRB submission documents for instances where marketing approval iswarranted. 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 asneededthe review and assessment of new opportunities and ESRs.

• Responsible fortimelyresponses to investigational study sites for local ICF changes protocol & EC/IRB questions/requests.

• Contribute todevelopmentand delivery of face to face or virtualinvestigatorand supervise training.

Essential Skills/Experience:

• BS

• Minimum of 3 years of relevant experience

• Industry or Academic experience in drug developmentwith experience in malignanthaematologyclinical 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 ClinicalPracticeother regulations governing clinical research.

• Ability to drive/contribute to protocol designwritingand implementation

Are you ready to make a difference Join us in our mission toeliminatecancer as a cause of death. Apply today!