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.
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.
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 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 Late Development Oncology, 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. Supportive team players, we draw on diverse knowledge from across the business and external partners to come to bear on the toughest medical challenges.
What you’ll do
The Global Development Scientist Director, Clinical Excellence and Innovation will report directly to the Head, Clinical Excellence and Innovation and is an important part of the Late Development Oncology (LDO) Clinical Excellence and Innovation (CEI) team. Our LDO CEI team is an innovative, entrepreneurial team shaping and conducting the LDO R&D mission in all matters relating to clinical excellence, including performance, knowledge sharing, external engagement, innovation, data technology, and digitalization.
Accountabilities include clinical support for the development and implementation of late phase AstraZeneca sponsored clinical strategies and drug development initiatives. You will provide clinical/scientific expert input, lead functional process improvements, and provide contributions to cross-asset or cross-tumor area working groups. You will act as a resource related to clinical excellence and innovation for oncology physicians, scientists, and study teams. There will be a heavy emphasis on innovation/technology and data with AI, automation, digital across multiple areas.
You will contribute collaboratively to LDO Clinical Development and broader cross-functional teams, to ensure clinical strategy is translated in the adoption of technology in oncology clinical trials. You will share responsibility with LDO Clinical Project Teams, Clinical Operations, and Digital in the planning, execution, scaling, and delivery of initiatives across assets and across tumor areas. You will maintain and expand current professional knowledge in innovation and technology as applied to patients with cancer and oncology clinical trials. You will mentor others, and participate or lead review as needed for new opportunities, depending on level of experience.
This position demands strong collaborative communication skills, including the ability to engage with and influence a diverse range of stakeholders both within and external to AstraZeneca. 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.
Essential for the role
- Bachelor’s degree with focus on life sciences or equivalent required
- Significant Industry or academic experience in drug development required with significant oncology therapeutic experience
- Possesses sound foundational knowledge of FDA and other major country regulations.
- Possesses detailed knowledge of Good Clinical Practice other regulations governing clinical research.
- Possesses general knowledge of 1) clinical data review and medical monitoring; 2) Regulatory approval process in relevant countries; 3) pharmaceutical industry/R&D operations; 4) marketing and commercial fundamentals.
- Drug Development/Clinical Development Planning: Demonstrates a proven ability to both independently complete, and lead peers in completion in components of complex plans, related documents, appropriate methodologies, measures, analytical plans and evaluation tools.
- Ability to drive/contribute to study document design, writing and implementation
- Strong communication & presentation skills to clearly communicate scientific concepts /data to leadership committees both internally or externally
Desirable for the role
- Either Ph.D. degree in life sciences or MD or other healthcare degree preferred
- Maintains a high degree of understanding and awareness of new and emerging clinical developments
- Strong leadership skills with the ability to influence others and drive consensus building
- Ability to contribute to, and as needed, lead development of clinical reports and integrated summary reports for complex projects
- Ability to take ownership and execute initiatives from idea to launch, including problem identification and prioritization, data gathering, problem solving, communicating recommendations, and driving results within an agile delivery model
- Ability to make data-driven decisions, hands-on action, and break down complex and ambiguous problems into steps
- Technology and digital experience
- Experience in several organizations and geographic locations
Location: Cambridge (preferable) UK or Gaithersburg US