Senior Group Director, Process Management and Clinical Execution, Early Onc

at  AstraZeneca

The Senior Group Director, Process Management and Clinical Execution is a pivotal strategic role reporting to the Head of Study Leadership. This position involves engaging with CPSO Leadership and collaborating closely with the Senior Group Directors for Study Leaders and the EO Study Operations leadership team.
The role is essential for identifying and leading process improvement initiatives and workstreams to achieve non-drug Early Oncology Clinical Group (EOCG) scorecard objectives. This includes a focus on Clinical Programs and Study Operations (CPSO) and broader EOCG initiatives for the benefit of the AZ enterprise. As a member of the extended CPSO Leadership Team (LT), you will promote, motivate, and empower others to achieve individual, team, departmental, and organizational goals. Exemplary collaborative communication skills are crucial for engaging with and influencing a diverse range of stakeholders both within and outside AstraZeneca.

ACCOUNTABILITIES:

Will be accountable for Process Management strategy and deployment for CPSO and EOCG (as applicable) in line with the evolution of portfolio requirements. Leads on identifying more efficient and effective methods and processes for executing high-quality clinical trials. This will require strategic development, review, and refinement of EOCG clinical processes. Areas of focus will include but not be limited to:

• Budget generation
• Clinical Data Insights
• Contracting and GCS support functions in Biopharm Clin Ops
• Drug Supply and E2E planning
• Deployment of Digital Solutions
• Works with CPSO Functional Process Experts (FPE), Subject Matter Experts (SMEs), Business Process Owners (BPO), and Study Leader Specialist roles to maintain oversight of existing processes required for EOCG clinical delivery
• Collaborates effectively with EOC Clinical Scientist and Physician groups, cross-therapeutic area teams, and cross-functional groups to deliver on objectives.
• Provides oversight of quality and compliance of the group to ensure inspection readiness liaising with both Clinical Quality and Compliance (CQC) colleagues and the Haematology R&D Director of Quality Management
• Contributes to the development and maintenance of CPSO stakeholder management framework, in collaboration with the CPSO LT
• Contributes to shaping and leading implementation of key functional activities in CPSO, in liaison with Head of Study Leadership and in alignment with business objectives.
• Ensures the group is compliant with training in line with company and regulatory standards
• May be required to line manage Director and Associate Director Study Leaders, including supporting project allocations/resource management, recruitment and selection, personal development, and performance management

ESSENTIAL SKILLS/EXPERIENCE:

• Bachelor’s degree or equivalent experience in a related field, preferably in medical or biological science.
• At least 10 years global drug development leadership experience with progressive levels of responsibility.
• Comprehensive knowledge of the clinical and pharmaceutical drug development process
• Demonstrable experience in clinical process improvements and high-value initiatives
• Strong strategic influencing skills; ability to influence broadly within and outside the organisation
• Proven ability in problem-solving and issue management that is solution-focused
• Proven experience of leading delivery through collaboration with internal and external providers
• Ability to lead, coordinate, and prioritise multiple tasks and deliverables
• Ability to manage change and actively seek and champion more efficient and effective ways of working
• Line management experience
• Experience and understanding of the study leader role including but not limited to:
• Use of project management techniques in complex projects, including resourcing and financial management
• Requirements for external contracts
• Oversight of external providers
• Experience of working with and delivering through strategic partners and 3rd party vendors
• Insourced and outsourced delivery models

DESIRABLE SKILLS/EXPERIENCE

• Early Oncology experience
• Process writing and generation
• Change Management
• Line Management
• Data management

• Budget generation
• Clinical Data Insights
• Contracting and GCS support functions in Biopharm Clin Ops
• Drug Supply and E2E planning
• Deployment of Digital Solutions
• Works with CPSO Functional Process Experts (FPE), Subject Matter Experts (SMEs), Business Process Owners (BPO), and Study Leader Specialist roles to maintain oversight of existing processes required for EOCG clinical delivery
• Collaborates effectively with EOC Clinical Scientist and Physician groups, cross-therapeutic area teams, and cross-functional groups to deliver on objectives.
• Provides oversight of quality and compliance of the group to ensure inspection readiness liaising with both Clinical Quality and Compliance (CQC) colleagues and the Haematology R&D Director of Quality Management
• Contributes to the development and maintenance of CPSO stakeholder management framework, in collaboration with the CPSO LT
• Contributes to shaping and leading implementation of key functional activities in CPSO, in liaison with Head of Study Leadership and in alignment with business objectives.
• Ensures the group is compliant with training in line with company and regulatory standards
• May be required to line manage Director and Associate Director Study Leaders, including supporting project allocations/resource management, recruitment and selection, personal development, and performance managemen