Senior Director Global Development Scientist Late

hace 3 semanas

Barcelona, España AstraZeneca A tiempo completo

**_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 commercialization 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. AstraZeneca 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. Late Development Oncology focusses on **Phase II-III studies.** **This role will support Oncology Lung studies.**

The **Senior Director Global Development Scientist Late Development Oncology Lung **is an important part of the Clinical Project Team (CPT), and Global Study Team (GST) working synergistically and cross functionally (in a matrix environment) with other CPT & GST members, Site Management & Monitoring (SMM), field-based liaisons, and site personnel. The Senior Global Development Scientist Director and counterpart Global Development Medical Director work collaboratively in the clinical aspects underpinning a clinical program. This includes the 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. 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).

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 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 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.

**Technical Skills**
- Drug Development/Clinical Development Planning: Demonstrates a proven ability to both independently complete, and lead peers in completion in components of complex plans, related documents, appropriate methodologies, measures, analytical plans and evaluation tools.
- Ability to drive/contribute to protocol design, writing and implementation to meet GCP, ICH and all AZ quality standards.
- Ability to leverage state of the art methodology in the design, conduct, review and interpretation, and presentation of clinical research.
- Maintains a high degree of understanding and awareness of new and emerging clinical developments to impact specific studies and clinical development plans.
- Shows greater independence in the development of options for study design and development of the statistical analysis plan.
- Can lead the development of content and rationales in assigned sections of clinical reports or regulatory/EC/IRB documents.
- Strong communication & presentation skills to clearly communicate scientific concepts /data to leadership committees (e.g LSPC, DRC, PRC) or external groups (e.g Investigator Meetings, IDMCs, Conferences Presentations)
- Strong leadership skills with the ability to influence others and drive consensus building
- Ability to contribute to, and as needed, lead development of clinical reports and integrated summary

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