AstraZeneca is a global, innovation-driven BioPharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines for some of the world’s most serious disease. But we’re more than one of the world’s leading pharmaceutical companies.
Global Clinical Operations Program Director:
- 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)
- Responsible for providing clinical operations expertise into the development of new business case opportunities for review by governance
- Lead cross functional 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 deliverables and the process to identify and solve or escalate operational issues. Drive delivery to plan through internal or external partners (alliance partners, Clinical Research Organizations (CROs), vendors and Academic Research Organizations (AROs)).
- Experience from leading clinical projects and deliverables 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
- 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
University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research.
10+ Years of Experience.
Field of Experience
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.
Attractive Salary Package