Global Development Scientist

hace 1 mes

Barcelona, España AstraZeneca A tiempo completo

**Opportunity**: Global Development Scientist - The Vaccines and Immune Therapies

**Business Area**: Vaccines & Immune Therapies Late Development
**Locations**: US: Gaithersburg/Durham, Sweden: Gothenburg, Spain: Barcelona

**Salary**: Competitive, with excellent benefits

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 Vaccines & Immune Therapies, 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.

The Vaccines and Immune Therapies (V&I unit) has been created to optimize AstraZeneca’s portfolio of vaccines and antibodies for infectious diseases (e.g. COVID, RSV, Influenza), as well as drive future discovery.

In AstraZeneca V&I, we’re driven by innovation and our commitment to make a real-life difference in patients’ lives. That difference starts with you. This is a place for those who thrive on energy and pace, we are rewarded and celebrated for our work, developing new medicines for patients.

**What you’ll do**

The Global Development Scientist is an important part of the Clinical Project Team, and Global Study Team working harmoniously and cross functionally with other team members, Site Management & Monitoring, field-based liaisons, and site personnel. The Global Development Scientist and Global Development Medical Director 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). You may also provide expert input or lead functional process improvement initiatives and provide contributions to cross area working groups depending on the level of experience.

This position demands strong collaborative communication skills and 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.

**Other responsibilities include but are not limited to**:

- Work cross functionally within clinical product teams (CPT to ensure the clinical strategy is translated into the development of the study concept document, study protocol and related documents.
- Develop relationships with appropriate consultants and key external experts (KEE), study sites, and utilize these relationships to obtain feedback on protocol design, as well as study training, study execution, interpretation of study results and inform recruitment strategies.
- Responsible for the relevance and accuracy of clinical science underpinning of clinical study based on detailed scientific review and consultation.
- Accountable for the clinical and scientific leadership and integrity of protocols, clinical study reports and/or components of clinical plans.
- Supports or leads interactions with global medical affairs, marketing companies, commercial, and regulatory functions in collaboration with GCH/GCPL to ensure cross functional input into protocols.
- Contributes to technical review of protocols with governance bodies such as DRC and PRC.
- Contributes to the development of Medical Oversight Plan (MOP), study level safety reviews and study-level medical monitoring activities.
- Responsible for the clinical and scientific input into a study and for the quality of the clinical data
- Contribute to advisory boards to ensure there is engagement with site specific KEEs to ensure robust study designs, recruitment strategies.
- Contributes to the review and interpretation of clinical data (HLRs) and the development of content needed for governance committee interactions seeking Go/No Go decisions.

**Essential for the role**
- Bachelor’s degree with focus on life sciences or equivalent
- Industry or academic experience in drug development
- Detailed knowledge of Good Clinical practice and other regulations governing clinical research.
- General knowledge of 1) medical monitoring 2) Regulatory approval process in relevant countries; 3) pharmaceutical industry/R&D operations; 4) marketing and commercial fundamental

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