AstraZeneca Looking for Global Clinical Development Scientist – vaccine and immune therapies at Mississauga, Ontario, Canada Full Time

Business Area: Vaccines & Immune Therapies Late Development

Locations: Gaithersburg (USA), Gothenburg (Sweden), Barcelona (Spain),

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 cutting-edge, where scientific innovations and an entrepreneurial spirit are the norm? We are building a team in AstraZeneca dedicated to Vaccines & Immune Therapies and are looking for passionate and motivated physicians with prior clinical development experience in immune therapies. We therefore are interested to hear from you to start exploring your future goals, objectives and career development paths.

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 this anticipated role in the Vaccines & Immune Therapies Unit, Late-stage Clinical Development function you will be given the opportunity to work on one or more of our current or new vaccine or monoclonal antibody programs for COVID-19, Respiratory Syncytial Virus (RSV) or Influenza, in a truly international working environment, with opportunities to interact with key external specialists, other medical colleagues and specialists in basic science, as well as commercial and regulatory functions.

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 thrive with 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 effectively 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 apply these relationships to acquire 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 clinical development documents as required
• Responsible for the clinical and scientific input into a study and the quality of the clinical data
• Engage with site specific KEEs to ensure robust study designs and 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 requirements:

• Minimum Bachelor’s degree with focus on life sciences or equivalent
• Prior experience in clinical development function gained in a global pharmaceutical company or equivalent
• Prior experience working on Vaccines or infectious disease therapy area
• Detailed knowledge /experience of Good Clinical practice and other regulations governing clinical research.
• Prior experience of 1) clinical trial data review 2) Regulatory approval processes for global studies; 3) analysis and interpretation of clinical trial results
• Ability to grow and maintain a high level of expertise in the vaccines & infectious diseases therapeutic area.
• Supporting tasks and activities for Clinical Development Planning and working with other functions to achieve successful study initiation and execution.
• Ability to drive/contribute to protocol design, writing and implementation

Desirable for the role

• MSc or Ph.D. degree in life sciences
• Emerging leadership skills with the ability to influence others and drive consensus building
• Emerging 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

Please apply via the link provided.

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

Why AstraZeneca?

Here you’ll have the opportunity to make a significant 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 complex diseases.

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