Head of Study Operations, Early Clinical Development - Cambridge, UK
- Full Time
Head of Study Operations, Early Clinical Development
Job reference: RD1743
At AstraZeneca we’re at the forefront of science; exploring solutions to unmet patient needs. Our Innovative Medicines (IMED) unit is at the heart of our unwavering commitment to breakthrough prescription biopharmaceuticals and Early Clinical Development (ECD) is a key driver of our ambitious plans for the future.
As Head of Study Operations within ECD you will provide overall direction, strategy, leadership and management of Clinical Sample Management, Clinical Study Co-ordination, and Alliance Management functions. As a leader within the organization, you will be instrumental in the concept, design, evolution, and deliverables of the Study Operations function to assure the highest quality execution of Clinical trials, on time and within budget. Reporting to the Head of ECD, you will be a key member of the Global Early Clinical Development management team and an important contributor to the overall success and industry leading positioning.
- Accountable to deliver clinical studies to industry leading quality, timelines and cost
- Deliver a strategic direction, broad leadership and effective management of the ECD Study Operations department
- Establish and maintain excellent alliance management across ECD departments and with key partners across IMED, with Global Medicine Development and MedImmune operations as appropriate and with relevant partners external to AstraZeneca
- Identify and establish an operating model for internal and external delivery of early clinical studies to enable flexible deployment of resources and projects
- Ensure operational excellence and continuous improvement in the Study Operations department; monitoring external trends and technology innovation in study operations, and adopting those which will improve Study Operations performance
- Set business standards and governance for outsourcing relevant study-related activities within ECD
- Manage resources (budgets and headcount) across assigned teams
- Line manage the Study Operations department; driving performance and the professional development of all direct reports
- Engage effectively with regulatory bodies and pharmaceutical/industry professionals to monitor, influence and leverage potential new industry trends or regulations
Essential Qualifications, Skills and Experience:
- Bachelor’s degree in an appropriate discipline
- Professional qualification
- Mastery of study management with an ability to lead cross functional working groups and teams
- Proven leadership abilities and experience promoting, motivating and empowering others to accomplish individual, team and organizational objectives
- Demonstrated ability to set and manage priorities, resources, performance targets and project initiatives in a global and regional environment
- Excellent written and verbal communication skills as well as proven negotiation, collaboration and interpersonal leadership skills
- Experience of leading a development team and working in a global environment
- Demonstrated conceptual, analytical and strategic thinking.
Desirable Qualifications, Skills and Experience:
- PhD in a scientific discipline or a medical degree
- Extensive knowledge of the latest technical and regulatory changes pertinent to study operations
- Operational expertise in risk management and contingency planning
- Familiarity with the latest clinical trial research innovations and thinking
Applications Open: Monday, 19th September
Applications Close: Friday, 30th September
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.