Study Management Director R&I
- Experience Level
- Senior Management
At AstraZeneca, we are guided in our work by a strong set of values, and we're resetting expectations of what a bio-pharmaceutical company can be. By truly following the science, we pioneer new methods, new thinking and bring unexpected teams together. From scientists to sales, lab techs to legal, we're on a mission to turn ideas into life-changing medicines that transform lives. We need great people who share our passion for science and have the drive and determination to meet the unmet needs of patients around the world. If you're swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you're our kind of person.
Study Management Director leads, develops and gives direction to the Study Management Organisation (SMO) Hub staff that is assigned to clinical drug projects and non-drug projects. The role holder is accountable for development of the operational capabilities to ensure skilled staff are available to support global clinical programs through delivery of clinical studies to agreed time, quality and budget. He/she is accountable for allocated budget and for maximizing the efficient utilisation of Hub resource. In addition, the role holder in collaboration with other Hub Directors is accountable for ensuring consistent ways of working across the SMO Hubs and therapy areas where appropriate.
As Study Management TA Director job holder is responsible for developing strategy and tactics to deliver studies within therapeutic area in the consistent and efficient way, and ensuring knowledge sharing across SMO resources allocated to the projects within therapeutic area of his/her responsibility.Typical Accountabilities:
As Hub Director
- Working in close collaboration with Study Management TA Directors accountable for timely and high-quality delivery of the studies assigned to SMO Hub
- Communicate the business priorities and vision to Hub staff ensuring adoption of globally agreed Clinical Operation strategies
- Provide strategic leadership to the Study Management organization in the assigned location to drive projects and performance
- Efficiently utilize Hub resources and capabilities to deliver agreed objectives in collaboration with Study Management TA Directors and Capacity Management Team
- Timely assignment of capable SMO resources to meet the clinical study team demands, in collaboration with other members of Study Management Leadership team, and the capacity management team
- Ensure that all studies in scope are delivered with right quality and according to AZ procedures and standards
- Ensure inspection readiness processes are in place for the studies in scope
- Manage assigned budget to plan.
- Lead and support change
- Attract, recruit, develop & retain top talent
- Develop, coach, mentor, empower and inspire SMO employees to achieve their fullest potential
- Ensure performance management and personal development of employees
- Ensure compliance to ethics, policies and standard procedures
- Line management of Hub Managers and Associate Director Quality Management
- Drive collaboration with relevant local departments - HR, Finance, IT, compliance, facility management - needed for the maintenance of the organisation and determination of local budget
- Working in close collaboration with Study Management Hub Directors accountable for timely and high-quality delivery of the studies in assigned TA
- Ensure knowledge sharing and consistent ways of working across SMO teams working within one therapeutic area
- Act as SMO main point of contact for Clinical operations TA Director and other partners within assigned TA to ensure good understanding of the TA priorities within SMO.
- Provide strategic leadership to the SMO in the assigned therapeutic area to drive projects and performance
- Drive an environment of global standardization and continuous improvement
- Contribute to the development and maintenance of global operational delivery models and options provided by Clinical Operations balancing customer needs and efficiency
- In collaboration with other members of Study Management Leadership team and key customers, develop and deliver performance targets and metrics for the operational study delivery ensuring effective risk planning and clarity of issues escalation pathway
- In collaboration with SMO Leadership team ensures the Study Management and Operations organization has the capability and resources required to deliver assigned studies, and build SMO capability and SMO organization for the future
- Drive and create a culture that fosters courageous, entrepreneurial, creative and collaborative behaviors
- Contribute to overall Clinical Operations performance
- Lead or contribute to a significant project or non- drug project deliverables that contribute to AZ business success
- University degree or equivalent preferably in life science
- Substantial experience in Pharmaceutical Industry in Clinical Development and Study Operations
- Significant experience of study management in assigned TA
- Extensive knowledge of clinical and pharmaceutical drug development process.
- Confirmed line management and leadership expertise, preferentially having led a large global group
- Demonstrated development of others, identifying and providing opportunities to improve the capabilities of other people
- Risk and crisis management experience
- Professional excellence: Background of high professional achievement and willingness to encourage this in others
- Manages 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 environment
- Ethics: Maintains high standards, including a commitment to AstraZeneca values, policies, and employment principles and policies.
- Cultural Awareness: Is aware of and sensitive to cultural differences and their impact on communication, expectations and performance.
- Teamwork and cross functional Collaboration: Is effective in leading and being a member of teams, both locally and internationally.
- Excellent communication skills
- Willingness to travel nationally and internationally
- Experience working internationally: working with major markets/resolution of international issues
- Experience of leading successful teams from more than one national culture
- Creative and Innovative: Seeks to improve continuously where it counts, based on good awareness of external competitive practice, and creativity and initiative.
- Scientific background, preferentially having worked across multiple therapeutic areas in Development
- Business planning skills: has knowledge/experience of planning processes used in leading drug projects
- Proven enterprise leadership consistently challenging the status quo and promoting motivation and empowerment of others in order to accomplish individual, team and organisational objectives
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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. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.