Director Study Operations

Responsible for leading, developing, supporting, and providing direction to Study Management personnel to enable delivery of drug projects and non-drug projects.  Accountable for resourcing Study Management members on study teams to support delivery of clinical programs. The role holder will also be responsible for embedding consistent ways of working across locations and building Study Management capabilities.

Ensure that direct reports are equiped with the right skills and capabilities to successfully lead and deliver clinical trials.  Take responsibility and act as a change agent to drive consistent implementation of globally agreed BioPharmaceuticals Clinical Operations strategies including processes and technology related to the delivery of studies.

Typical Accountabilities:

1- Line management of Study Management Late staff

• Recruit, Retain & Develop personnel
• Demonstrate AZ values
• Provide skills and capability training to personnel to support their development
• Ensure personnel have been trained and work within compliance of ethics, company policies and standard procedures
• Role model and embed a performance driven culture and coach staff for optimum performance
• Develop and nurture capabilities of our present and future AZ leaders
• Manage performance including feedback and rewards
• Provide expertise and direction to support direct reports with proactive problem/risk identification, solution building and issue resolution to facilitate achievement of objectives on time and to appropriate quality
• Timely assignment of capable Study Management resources to meet the clinical study team demands, in collaboration with other members of Study Management Leadership team, and the Capacity Management Team 

2- Study Management

• Participate in setting, and responsible for implementing, the vision & strategy for the Study Management, aligned with BioPharmaceuticals ClinicalVision & Strategy
• Contribute to business strategy and streamline processes for drug/non-drug projects or departmental activities
• Lead and support change by encouraging diversity of solutions and implementing process changes consistently across Study Management
• Act as a change Agent, with local and global impact, to ensure adoption of global initiatives
• Promote and encourage innovation and creativity
• Work within Study Management to achieve accurate resource forecasting and develop solutions to efficiently and flexibly resource study teams
• Promote and encourage communication within and across Study Management and BioPharmaceuticals Clinical
• Ensure quality and compliance to External Regulations and AZ Standards
• Work across the locations to develop global efficient ways-of-working
• Provide expert input into functional and cross-functional global processes
• Foster the sharing of study delivery knowledge, information, and best practice

Essential requirements:

• Bachelor’s degree required, preferably in medical or biological science, or related subject or equivalent qualification or experience.
• 10 or more years of experience in the pharmaceutical industry
• Comprehensive experience of clinical and Drug Development process within a pharmaceutical or clinical background
• Proven leadership and ability to promote motivation and empower others in order to accomplish individual, team and organizational objectives
• Thorough knowledge of Study Management processes in both local regulation and global environment
• An understanding of the therapeutic areas related to AstraZeneca’s products
• Strong leadership, problem solving, stakeholder management and conflict resolution skills
• Ability to lead change with a positive approach to the challenges of change for self, team, and the business. Sees change as an opportunity to improve performance and add value to the business
• 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, negotiation, collaboration and interpersonal skills

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.