Global Development Scientist Director Late Oncology

At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation – ultimately providing employees with the opportunity to work across teams, functions and even the globe.

 Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week. Our head office and BlueSky Hub in downtown Toronto are purposely designed with collaboration in mind, providing space where teams can come together to strategize, brainstorm and connect on key projects.

 Our dedication to sustainability is also central to our culture and part of what makes AstraZeneca a great place to work. We know the health of people, the planet and our business are interconnected which is why we’re taking ambitious action to tackle some of the biggest challenges of our time, from climate change to access to healthcare and disease prevention.

Oncology Research & Development, Late Development Oncology

Our ambition is to eliminate cancer as a cause of death. It’s our big vision that unites and encourages us. With multiple indications and high-quality molecules at all stages of our innovative pipeline, we keep pushing forward. Focusing on ground breaking science with the latest technology to achieve breakthroughs.   AZ is a place built on courage, curiosity and collaboration – we make ambitious decisions driven by patient outcomes.

What you’ll do

The Medical Scientist is an important part of the Clinical Project Team (CPT), and Global Study Team (GST) working harmoniously and cross functionally (in a matrix environment) with other CPT & GST members, Site Management & Monitoring (SMM), field-based liaisons, and site personnel. The Medical Scientist and counterpart Study Physician 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 asset or cross tumor area working groups depending on the level of experience.

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 advise 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 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.

• Drug Development/Clinical Development Planning: Demonstrates the ability to undertake the 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 drive/contribute to protocol design, writing and implementation

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

Desirable for the role

• Advanced or Ph.D. degree in life sciences

• Oncology experience

• Strong experience with regulatory submission and related activities

• 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
  

Great People want to Work with us! Find out why:

• GTAA Top Employer Award for 9 years
• Learn about our culture
• Learn more about working with us in Canada
• View our YouTube channel

Are you interested in working at AZ, apply today!

AstraZeneca is an equal opportunity employer that is committed to diversity and inclusion and providing a workplace that is free from discrimination. AstraZeneca is committed to accommodating persons with disabilities. Such accommodation is available on request in respect of all aspects of the recruitment, assessment and selection process and may be requested by emailing AZCHumanResources@astrazeneca.com