Director, Study Management (Cell Therapy)

TheDirector, Study Management (DSM)is responsible for leading, developing, supporting, and providing direction to the Study Management team for project, TA/scientific/technical, and operational related issues to enable delivery of drug projects and non drug projects. The DSM is accountable for resourcing members on study teams to support delivery of clinical programs in R&D. The role holder will also be responsible for embedding consistent ways of working across Hubs and building study management capabilities. 

 The DSM will ensure that direct reports are equipped 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 Clinical Operations and Clinical Development strategies including processes and technology related to the delivery of studies. 

Line management of Cell Therapy Study Management staff 

• Recruit, retain & develop talent. 

• Demonstrate AZ values. 

• Facilitate skills and capability training to Study Management team members to support their development. 

• Ensure team members 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 feedforward and reward. 

• 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. 

Delivery of projects 

• Maintain dialogue with Senior Director, Study Management and Senior Global Program Director to anticipate project requirements and mitigate risks to project delivery. 

• Allocate appropriately skilled team members to study delivery teams to ensure delivery of clinical studies to time, budget and quality standards in accordance with clinical performance targets. 

• Ensure staff understand global project priorities and specific project challenges: support staff/team to achieve project milestones and study deliverables. 

• To work across departments to support the delivery of projects and organizational improvements. 

Leadership 

• Participate in setting, and responsible for implementing, the vision & strategy for the Cell Therapy Study Management team, aligned with Clinical Operations and Cell Therapy’s Vision & 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 the organization. 

• Act as a change agent, with local and global impact, to ensure adoption of global initiatives. 

• Promote and encourage innovation and creativity. 

• Work with Leadership team and Global Study Leads to achieve accurate resource forecasting and develop solutions to efficiently and flexibly resource study teams. 

• Promote and encourage communication within and across therapeutic areas

• Ensure quality and compliance to External Regulations and AZ Standards. 

• Work across the Hubs 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 on individual performance to the study team members and their line managers to support their professional development; may mentor less experienced colleagues. 

Education, Qualifications, Skills and Experience

Essential:

• Bachelor’s degree required, preferably in medical or biological science, or related subject or equivalent qualification or experience. 

• Experience in the pharmaceutical industry. 

• Line management experience. 

• 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 Cell Therapy. 

• 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 

• Negotiation, collaboration and interpersonal skills. 

Desirable:

• Advanced degree in a scientific discipline. 

• Expert reputation within the business and Industry. 

• Extensive knowledge of the latest technical information. 

• Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time.