Director, Global Clinical Development Scientist, Vaccines and Immune Therapies
Found in: Jooble CA O C2 - 1 week ago
Global Clinical Development Scientist – Vaccines and Immune Therapies
Business Area: Vaccines & Immune Therapies Late Development
Do you have expertise in, and passion for clinical drug development? Are you looking to work at the ground breaking, where scientific innovations and an ambitious spirit are the norm? Join the team at the heart of AstraZeneca dedicated to Vaccines & Immune Therapies, committed to following the science.
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 built 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 dedication to make a real-life difference in patients’ lives. This is a place for those who grow with energy and pace, we are rewarded and celebrated for our work, developing new medicines for patients.
The Senior 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 effectively on time, and activities required for worldwide registration of the product (i.e. clinical input to NDA/BLA). 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 implement to Good Clinical Practice (GCP) and regulatory requirements.
Works harmoniously and cross functionally with other global Study Team and Clinical Project Team members.
Works within one or more vaccine or monoclonal antibody asset to provide clinical scientific support.
Develops skills to ensure the clinical strategy is translated into the development of key study documents, e.g. study specification (study synopsis), clinical study protocol, informed consent form, investigator brochure, case report form, electronic diaries, etc.
Learns skills to train on the study protocol and key study design elements to Investigator sites and third-party vendor staff e.g. Supports oversight activities of third-party vendors where clinical/ medical responsibilities have been outsourced, including providing input and guidance on third party documentation to ensure data integrity and protocol compliance.
Learns and provides support for clinical and medical data review during the conduct of the study through to final database lock and raises clinically related data queries.
Reviews and provides scientific and clinical input / interpretation into review of study results (tables, listings, and figures) and clinical study reports to meet reporting timelines.
Provides clinical input into regulatory submission activities, including responses to Health Authority questions for CTAs, NDAs, BLAs, MAAs and EUAs as applicable).
Supports activities for interactions with advisory boards with key external experts (KEEs) and study sites and utilize their feedback on clinical study protocol design / feasibility, study training, study execution, study results interpretation and to inform recruitment strategies.
Provides administrative support for key clinical scientist activities, including safety data tracking.
Bachelor’s degree with focus on life sciences or equivalent
At least 2 years industry or academic clinical trial unit experience in drug development at different phases
Experience in vaccines and infectious diseases with an ability to grow and maintain a high level of expertise in these areas.
Experience in planning, and timely organization of components of the clinical development plan and work with other functions to achieve successful study initiation and execution.
Ability to contribute to protocol design, writing and implementation.
Willing to develop leadership and influencing skills, in drug development and the pharmaceutical industry
Experience of working with the Microsoft suite of software (Word, Excel, Powerpoint etc), relational clinical databases (e.g. RAVE) and data visualization tools.
Good communication & presentation skills to communicate scientific concepts/data clearly and crisply in team settings and in formal presentations to leadership committees both internally and externally.
The role is office based with some home/ office based flexibility offered.
Answer unmet medical needs by ground-breaking the next wave of science, focusing on outcomes and crafting the patient ecosystem.
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#AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.
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