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.
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 ground-breaking 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. Late Development Oncology focuses on phase II - III clinical trials. 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.
This position will focus on Lung Oncology. Global Clinical Program Lead
The Global Clinical Program Lead is accountable to the Global Clinical Head for a significant proportion of the Clinical Program, usually an indication-aligned cluster of clinical studies. This role is normally applied to portions of the Program that have a high degree of complexity based upon the known science or the size of the program, and/or due to a third-party collaboration that requires an incumbent to exercise greater expertise and judgement as well as to be effective in influencing and working across multifaceted partnerships. They will be required at times to deputise for the Global Clinical Head.
You will work with the study physicians to support the design, conduct, monitoring and data interpretation of the studies to ensure that the clinical data collected within the studies will allow determination of the benefits and risks of the compound and meet the needs of the intended label indication and price in markets globally. You'll be expected to be strategic, generate opportunity and value for the asset or indication and be entrepreneurial to maintain a competitive advantage.
The individual could lead the Clinical Project Team (CPT) and set team vision and goals against Therapy Area Leadership Team (TALT) and product strategy, align team against timely decision making, facilitate balancing of cost/time/quality against clinical development objectives, ensure forward risk mitigation strategies, enable quick and effective trouble shooting, represent product at health authority interactions, act as Publication Sign-Off (PSO) Lead or delegate, rapidly implement new processes and systems and sharing/seeking learning through your portfolio of studies.
You will operate according to the highest ethical standards in compliance with internal SOPs, local regulations, laws and adhere to Good Clinical Practice and regulatory requirements.
Typical Accountabilities, what you will be doing Clinical Program Team Leader (if relevant)
- Accountable for the CPT deliverables.
- Overall clinical and scientific content for the product or indication(s) aligned to Global Product Team (GPT) strategy.
- Sets team vision and goals aligned to TALT and product strategy.
- With the Director Clinical Director (DCD), ensure the CPT rapidly implements new processes, systems and learning.
- Prioritization of clinical activities within the clinical program and ensures forward looking risk mitigation strategies.
- Through end-to-end knowledge of drug development and situational leadership capabilities, promotes and enables cross-functional, proactive and solutions-orientated team actions and behaviours.
- Enables quick and effective trouble shooting within the CPT and its associated sub-teams.
- Coaches individual team members as needed, building future AZ talent through the matrix team model.
- Acts as PSO sign off (lead or delegate).
- Single point accountable leader for the design, delivery and interpretation of clinical studies ensuring the ethical and scientific integrity of the plans, studies and products in compliance with AZ policies and Good Clinical Practice.Clinical expert accountabilities
- Is accountable for study designs and study design concept delivery within their assigned program of studies.
- Through integrated understanding of the product strategy, provides strategic clinical and scientific knowledge and support to the Study Physicians for initiation, execution and completion of the clinical studies within the assigned portion of the Program.
- Accountable to represent the company and deliver clinical information.
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