Global Clinical Operations Program Director
hace 4 semanas
**Job Title: Global Clinical Operations Program Director**
**Location: Office Based Role w Flexibility in Boston Seaport**
We have an exciting opportunity to join our team as a Global Clinical Operations Program Director within the Clinical Operations function of Late Stage development in Respiratory and Immunology (R&I) Therapeutic Area.
Building on a 50-year heritage in respiratory care, our ambition is to transform the treatment of asthma and chronic obstructive pulmonary disease (COPD) by driving earlier, biology-led treatment, eliminating preventable asthma attacks, and removing COPD as a top-three leading cause of death. Underpinning chronic lung diseases is an altered immune system. We are following the science of common pathways and underlying disease drivers from respiratory disease into immunology-driven disease areas. The disease areas we’re targeting include rheumatology (including type 1 interferon-driven diseases such as lupus), dermatology, gastroenterology and systemic eosinophilic-driven diseases. Our ambition is to achieve disease modification and durable remission in these diseases for millions of patients worldwide.
**What you’ll do**
As a Global Clinical Operations Program Director you will work in a global role within the Clinical Operations function of Late Stage R&D (Biopharmaceuticals). The span of responsibilities is broad and may support one or several products depending on their size and complexity. The products supported may include studies in all phases of drug development.
The Global Clinical Operations Program Director is responsible for oversight of a program of global studies, covering all clinical development results. The role also involves integrating design, feasibility and operational planning to ensure clinical drug development programs are aligned with priorities and strategy. The role will provide input & support to the Senior Global Clinical Operations Program Director in preparation for new business case opportunities for review by governance interactions and may act as the lead for cross-functional teams in delivery of various clinical activities and manage improvement or change projects within clinical operations or spanning multiple business areas.
**Typical Accountabilities**:
- Lead cross functional teams of experts in the planning and delivery of a defined clinical program of studies and/or clinical activities to scope, quality, budget, time, planning the resource and managing risk.
- Work closely with global study leaders to provide appropriate strategic oversight of a program of studies on behalf of Sr Global Clinical Operations Program Director and Clinical Program Team (CPT)
- Lead Clinical Submission Teams in planning and execution of clinical contribution to Marketing Applications, maintenance support for regulatory interactions and reports and inspection readiness.
- Lead large or complex projects and the process to identify and solve or raise operational issues. Drive delivery to plan through internal or external partners (alliance partners, Clinical Research Organizations (CROs), vendors and Academic Research Organizations (AROs)).
**Essential Education, Experience and Skills Required for the Role**
- University degree (or equivalent), preferably in medical or biological sciences or specialty associated with clinical research.
- At least 10 years’ experience from within the pharmaceutical industry or similar large multinational organization and proven experience of clinical development / drug development process in various phases of development and therapy areas.
- Experience from leading clinical projects or similar expertise from other areas of drug development (such as pharmaceutical development) and proven knowledge of project management tools and processes
- Proven leadership promoting motivation and empowerment of others in order to accomplish individual, team and organizational objectives. Ability to mentor, develop and educate staff
- Excellent written and verbal communication skills, negotiation, collaboration and interpersonal skills with ability to work effectively with others at all levels of the organization
**Desirable Education, Experience and Skills for the Role**
- Project management certification
- Knowledge of process improvement methodology such as Lean Sigma/Change Management
- Regulatory submission experience
- Proven knowledge of clinical operations
- Experience with development and implementation of digital health initiatives in Clinical Studies
This is an exciting opportunity for professional growth in areas of drug development, science, and leadership. If you’re inspired by the possibilities of science to make a difference and ready to discover what you can do - join us
**AstraZeneca an Employer of Choice**
At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines
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