Director, Global Clinical Development Scientist, Vaccines and Immune Therapies

Opportunity: Global Clinical Development Scientist – Vaccines and Immune Therapies

Business Area: Vaccines & Immune Therapies Late Development
Locations: Mississauga, Canada

Salary: Competitive, with excellent benefits

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.

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 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. That difference starts with you. 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.

What you’ll do

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). You may also provide authoritative 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 implement to Good Clinical Practice (GCP) and regulatory requirements.

Other responsibilities include but are not limited to:

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. CRAs.

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.

Is solution orientated applying gained experience to facilitate issue resolution. 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 internal governance activities where required.

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 input into functional process improvement initiatives within V&I or AstraZeneca.

Provides administrative support for key clinical scientist activities, including safety data tracking.

The role requirements:

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

Working knowledge of ICH GCP and other regulations governing clinical research.

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.

Demonstrates a basic understanding of methodology in the design, conduct, review and interpretation, and presentation of clinical research.

Good organizational skills, an attention to detail, strong collaborative communication skills

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.

Desirable for the role

MSc degree in life sciences.

Strong preference to further develop a career in vaccines and infectious disease.

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.

Please apply via the link provided.

For further details please contact beata.klecz@astrazeneca.com

Why AstraZeneca?

Here you’ll have the chance to define a meaningful difference to patients’ lives. With science at its heart, this is the place where breakthroughs born in the lab become transformative medicines – for the world’s most sophisticated diseases. Answer unmet medical needs by ground-breaking the next wave of science, focusing on outcomes and crafting the patient ecosystem.

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Date Posted 20-Feb-2024

Closing Date 29-Apr-2024

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. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements. #J-18808-Ljbffr

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