This opportunity is available at Barcelona onsite location.
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 help eliminate cancer 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, 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
Are you ready to make a difference? Join us in our mission to eliminate cancer as a cause of death. Apply today!
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