Associate Director Global Development Scientist Hematology

Join our Hematology R&D team at AstraZeneca where we are committed to advancing the science to deliver lifechanging medicines to patients most in need. Our focus is on a combinationfocused 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 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

Relevant experience

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

Sufficient technical knowledge (haematooncology 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!

Date Posted

Closing Date

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 industryleading 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 nondiscrimination in employment (and recruitment) as well as work authorization and employment eligibility verification requirements.