Director, Global Dev Scientist
hace 7 meses
**_This opportunity is available at our Gaithersburg, MD, Waltham, MA (USA); Mississauga (CAN); or Barcelona (ESP) location._**
Within Hematology R&D, 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 the 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. Accountabilities include clinical support for the development and implementation of early and/or late phase AstraZeneca sponsored clinical program strategies. As such, you will provide scientific input into design & implementation of clinical trials, 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).
The Global Development Scientist Director may also provide expert input or lead functional process improvement initiatives and provide contributions to cross-asset or cross-tumor area working groups depending on the level of experience.
This position demands strong collaborative communication skills, including the ability to engage with and influence a diverse range of stakeholders both within and external to AstraZeneca. The individual will operate according to the highest ethical standards in compliance with internal SOPs, local regulations, laws and adhere to Good Clinical Practice (GCP) and regulatory requirements.
**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.
**Minimum Qualifications**:
- BS required
- Minimum of 5 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 prefe
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