Global Clinical Operations Program Director
hace 2 semanas
**About Biopharmaceutical Clinical Operations Vaccines and Immune Therapies**
Do you have expertise in Clinical Operations, and a passion to support delivery of Clinical Development Programs? If yes, then we are recruiting for a key role within the Vaccines and Immune Therapies Clinical Operations group in AZ.
BioPharmaceuticals Clinical Operations is a diverse, international team focused on the end-to-end planning and delivery of patient-centric clinical trial programs and studies, enabling submissions for the AstraZeneca portfolio.
We work throughout the clinical lifecycle and leverage our expertise to design and deliver sustainable trials with short clinical cycle times and an excellent patient experience.
The Vaccine and Immune Therapies unit is committed to protect and treat the most vulnerable populations, through development of vaccines and/or monoclonal antibodies. We are focused on developing medicines that provide an effective and long-lasting immunity.
**What will you do?**:
As Global Clinical Operations Program Director you will work in a global role in the Clinical Operations function for the Vaccines and Immune Therapies unit. The span of responsibilities is broad and goes from clinical program design & planning through to data readout and analysis, clinical submissions and clinical maintenance activities. The clinical programs may include studies in all phases of drug development.
A Global Clinical Operations Program Director plays a pivotal role collaborating closely with the Senior Global Clinical Operations Program Director and the global cross-functional teams responsible for the delivery of clinical studies. You will also have the opportunity to provide input to optimize trial execution, coordinate governance interactions and product strategy
**The role is typically responsible for**:
- Oversight across a program of global studies covering all clinical development deliverables including aspects of quality, resources, budget, timelines and risks.
- The role also involves integrating study design, feasibility and operational planning to ensure clinical drug development programs are aligned with company priorities and strategy and delivered in accordance with Clinical Development plans, GCP guidelines and internal procedures. Notice that this is not a study management/delivery position.
**Essential education, skills and experience for the role**:
- University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research
- At least10 years’ experience within pharmaceutical industry or similar biotech global industry
- Proven global experience of clinical development/drug development process across various phases
- Experience leading clinical projects
- Proven leadership skills, ability to set and lead priorities
- Ability to motivate and empower others
- Excellent communication skills, including negotiation
- Flexibility and adaptability
- Collaboration and stakeholder management both internally and externally
- High ethical standards
**Desirable for the role**:
- Experience in vaccine development/clinical trials or working in infectious disease area
- Regulatory submission experience
- Knowledge of process improvement and change management methodology
- Experience in driving/leading non-prograM/Functional workstreams and initiatives
- Experience in development and implementation of digital health and patient centric strategies into clinical studies
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