Global Development Director Scientist

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 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). 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), including studies involving immunotherapy and cell therapy approaches, 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.

• BS required, PhD in a scientific field, PharmD or MD is strongly preferred

• 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 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.

• Possesses general knowledge of 1) medical monitoring 2) Regulatory approval process in relevant countries; 3) pharmaceutical industry/R&D operations; 4) marketing and commercial fundamentals.

• Drug Development/Clinical Development Planning: Demonstrates a consistent track record to both independently complete, and lead peers in completion in components of sophisticated plans, related documents, appropriate methodologies, measures, analytical plans and evaluation tools.

• Ability to drive/contribute to protocol design, writing and implementation.