Global Development Scientist Director- Lung Late Stage Dev. Onc.
Lung, 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 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).
The Global Development Scientist Director 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 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.
Depending upon experience level, the role will mentor the development of less experienced members of the clinical team, and may involve direct line management.
Other responsibilities include but are not limited to:
- Work cross functionally within CPT to ensure the clinical strategy is translated into the development of the study concept document, study protocol and related documents
- Significant contributor to the development of program strategy for assigned compounds/programs and work with GPT/CPT members to develop a compelling business case for governance approval.
- Provide expert clinical input to shape the study design via collaboration with primary investigators, key external experts (KEE), study sites, team members, and internal stakeholders, such that it reflects clinical practice, evolving landscape, regulatory and reimbursement requirements and meets the strategic program objectives.
- Participate or lead as needed the review and assessment of new opportunities and ESRs.
- Accountable for the relevance and accuracy of clinical science underpinning of clinical study based on detailed scientific review and consultation, for the clinical and scientific leadership and integrity of protocols and/or components of clinical plans and for the delivery of final protocol and its governance approval.
- Provides expert input into/lead the development of the protocol and related documents and the development and delivery of the clinical study report
- Supports or leads interactions with global medical affairs, marketing companies, commercial, in collaboration with GCH/GCPL to ensure cross functional input into protocols.
- Responsible for timely responses to investigational study sites for local ICF changes, protocol & EC/IRB questions/requests. Contribute to development and delivery of face to face or virtual investigator and monitor training.
- Support the development of clinical components of regulatory and EC/IRB submission documents for instances where marketing approval is warranted.
Essential for the role
- Bachelor’s degree with focus on life sciences or equivalent
- 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) 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 protocol 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, PharmD, or MD
- Maintains a high degree of understanding and awareness of new and emerging clinical developments to impact specific studies and clinical development plans.
- 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
- Shows greater independence in the development of options for study design and development of the statistical analysis plan.
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.
So, what’s next?
- Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you!
Where can I find out more?
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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 authorisation and employment eligibility verification requirements.