Sr. Global Development Scientist Director, Lung
hace 5 días
**Lung, Research & Development, Late Development Oncology**
**Our ambition is to eliminate cancer as a cause of death**. It’s our big vision that unites and inspires us. With multiple indications and high-quality molecules at all stages of our innovative pipeline, we keep pushing forward. Focusing on cutting-edge science with the latest technology to achieve breakthroughs. AZ is a place built on courage, curiosity and collaboration - we make bold decisions driven by patient outcomes.
Within **Late Development Oncology,** we push the boundaries of science to change the practice of medicine and transform the lives of patients living with cancer. With one of the broadest and deepest Oncology pipelines in the industry, there are many opportunities to work with new and novel drugs and help discover what’s next. Supportive team players, we draw on diverse knowledge from across the business and external partners to come to bear on the toughest medical challenges.
**What you’ll 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 Medical Scientist and counterpart Study Physician work collaboratively in the clinical aspects underpinning a clinical program. 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 late phase AstraZeneca sponsored clinical program strategies. As such, you will provide clinical/scientific input into design & implementation of clinical trial(s), their delivery, clinical data review, 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. Depending upon experience level, the role will mentor the development of less experienced members of the clinical team, and may involve direct line management.
Other responsibilities include but are not limited to:
- 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
- Significant contributor to the development of program strategy for assigned compounds/programs and work with GPT/CPT members to develop a compelling business case for governance approval.
- Provide expert clinical input to shape the study design via collaboration with primary investigators, key external experts (KEE), study sites, team members, and internal stakeholders, such that it reflects clinical practice, evolving landscape, regulatory and reimbursement requirements and meets the strategic program objectives.
- Participate or lead as needed the review and assessment of new opportunities and ESRs.
- 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.
- Provides expert input into/lead the development of the protocol and related documents and the development and delivery of the clinical study report
- Supports or leads interactions with global medical affairs, marketing companies, commercial, in collaboration with GCH/GCPL to ensure cross functional input into protocols.
- 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 monitor training.
- Support the development of clinical components of regulatory and EC/IRB submission documents for instances where marketing approval is warranted.
**Essential for the role**
- Bachelor’s degree with focus on life sciences or equivalent
- ** Significant Industry or academic experience in drug development required with oncology therapeutic experience**
- Possesses sound foundational knowledge of FDA and other major country regulations.
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