This opportunity is available at our Gaithersburg, MD, Waltham, MA (USA); Mississauga (CAN); or Barcelona (ESP) location.
Within Hematology RD, we are committed to advancing the science to deliver life-changing medicines to patients most in need.
With a combination-focused pipeline that exploits the power of six scientific platforms (Immuno-Oncology, Tumor Drivers and Resistance, DNA Damage Response, Antibody-drug Conjugates, Cell Therapy, and Epigenetics) to help address unmet clinical needs in a host of hematological cancers, we are motivated by a dedication to scientific discovery and collaboration that will one day help eliminate cancer as a cause of death.This unit has responsibility for the value chain from discovery through to late-stage development, enabling rapid acceleration of promising early-stage assets and life-cycle management programs.What you will do:The Global Development Scientist Director is an important part of the Clinical Project Team (CPT) and Global Study Team (GST), working harmoniously and cross-functionally (in a matrix environment) with other CPT GST members, Site Management Monitoring (SMM), field-based liaisons, and site personnel.
The Global Development Scientist Director and counterpart Global Development Medical Director work collaboratively in the clinical aspects underpinning a product.
This includes shared responsibility with Clinical Operations team members in the planning and execution, including recruitment and delivery of a clinical study.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 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.
#J-18808-Ljbffr
