Global Development Scientist
hace 3 semanas
Do you have expertise in, and passion for clinical drug development? Are you looking to work at the cutting-edge, where scientific innovations and an entrepreneurial spirit are the norm? Join the team at the heart of AstraZeneca dedicated to Oncology, committed to following the science.
**About AstraZeneca**:
AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines for some of the world’s most serious diseases. We are more than one of the world’s leading pharmaceutical companies.
**Oncology 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 is an important part of the Clinical Project Team (CPT), and Global Study Team (GST) working collaboratively and cross functionally (in a matrix environment) with other CPT & GST members, Site Management & Monitoring (SMM), field based liaisons, and site personnel. You will partner with a Global Development Medical Director in the clinical aspects underpinning a clinical program. Both will share the responsibility with Clinical Operations team 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. This includes providing clinical 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).
In this role, you 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.
As a key member of the clinical team, this position demands strong collaborative communication skills, including the ability to engage with and influence a diverse range of collaborators 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 and regulatory requirements.
**Other responsibilities include but are not limited to**:
- Supports drafting and review of clinical scientific documents such as IND, IND amendments, Investigator Brochures, Annual Reports and other Health Authority submissions.
- Assists in the implementation of protocols and interactions with vendors and CROs, working closely within cross functional team. Participates in the development of producing materials for investigator meetings (e.g., slides, booklets, and presentation materials). Assists in triaging and addressing questions regarding scientific and protocol procedures from other study team members and investigative sites.
- Support review of clinical data to identify and evaluate study data trends, outliers, protocol violators, etc and write any vital queries to be communicated to sites to ensure data accuracy and completeness of the study.
- Participate in safety review meetings regarding potential safety events within a given clinical study or across the assigned clinical program. Ensure updates to safety information is shared with cross functional study team. Help review safety narratives.
- Supports preparation of abstracts, manuscripts, publications and poster presentations of clinical study findings and results throughout the life cycle of the assigned study or product, as applicable. Supports medical affairs activities, payer and reimbursement activities.
- Assists with drafting assigned sections of clinical reports, dossiers and other documents.
- Support Data Management in the build of the CRF and all associated instructions and plans (e.g. CRF completion instructions and Data Review Plan).
- Serves as medical/clinical science representative on study team and collaborates cross-functionally on applicable deli
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