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.

These roles may be located in the US (Gaithersburg, MD, Waltham MA, NYC), Barcelona, Spain; Mississauga, Canada; or Warsaw, Poland. These roles are hybrid, aligned to the office and full time remote work is not an option.

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. 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. AZ is a place built on courage, curiosity, and collaboration – we make bold decisions driven by patient outcomes.

Within the Clinical Development teams in Oncology R&D, 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.

What you’ll do

Global Clinical Development Scientists, at all levels, are a critical part of the Clinical Development framework working harmoniously and cross functionally in a matrixed environment. The Clinical Development Scientist and counterpart Clinical Development Medical Directors work collaboratively on the clinical aspects underpinning a clinical program including the planning and execution and delivery of a clinical study. You will provide clinical/scientific input into design & implementation of clinical trials, their delivery, clinical data review, interpretation of results, reporting successfully on time, and activities required for worldwide registration of the product. 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. This role 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 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, and components of clinical plans.

• Supports or leads interactions with global medical affairs, marketing companies, commercial, and regulatory functions

• 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

• 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 GCP 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 fundamentals.

• Ability to grow and maintain a high level of expertise in oncology therapeutic area.

• Demonstrated experience in Drug Development/Clinical Development Planning knowledge and experience

• Ability to drive/contribute to protocol design, writing and implementation

• Solid understanding of methodology in the design, conduct, review and interpretation, and presentation of clinical research.

Desirable for the role

• Masters or Ph.D. degree in life sciences

Why AstraZeneca? Here you’ll have the opportunity to make 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 complex diseases. Answer unmet medical needs by pioneering the next wave of science, focusing on outcomes and shaping the patient ecosystem.

Where can I find out more?

Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/

Follow AstraZeneca on Facebook https://www.facebook.com/astrazenecacareers/

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