Clinical Research & Development Director

What You Will Do Externally recognized as a thought leader with deep expertise in both clinical research and development with deep understanding of autoimmune disease, specifically inflammatory myopathies, JIA and/or Sjogren’s disease. Knowledge and expertise in cell therapy is a plus . Drive the integrated clinical research and development strategy and execution, to ensure value creation and regulatory/market success through innovative, cross-functional leadership. Operate independently and at scale, influencing both operational excellence and strategic direction at the highest organizational levels. Typical Accountabilities • Develop and align strategies and objectives for Clinical Research & Development, ensuring they support AstraZeneca’s global goals and product vision. • Lead and oversee execution and delivery of clinical research & development studies, ensuring scientific rigor, commercial viability, and patient-centric focus throughout the drug lifecycle. • Lead the work with Line Managers to identify resource need and secure resources to ensure flexible and timely formation of the Clinical Research & Development Teams and progression of deliverables • Provide strategic and operational input to ensure implementation of best practices, new technologies , processes, and global clinical strategies. • Manage resource planning in collaboration with line managers, securing talent and flexible teams to support dynamic project requirements. • Oversee budgeting, timelines, contingency and risk management planning, and escalate operational or strategic issues as appropriate. • Lead the negotiation and management of contracts with CROs and external service providers. • Drive the preparation, review, and delivery of regulatory submission materials and actively participates in regulatory defense /approval processes. • Has personal responsibility for creating a culture of courageous leadership, creativity and collaboration • Mentor, develop, and manage performance of line management and project teams, ensuring alignment with organizational goals and fostering succession planning. • Ensure all work is compliant with internal and external standards, including Safety, Health, Environment, and regulatory guidelines. Qualifications and Skills Essential : Advanced degree (Master’s, PhD, or equivalent) in a scientific, medical, or health-related discipline ; Extensive experience in both clinical research and clinical development within the pharmaceutical or biotechnology industry ; Familiarity with the scientific and clinical community ; Proven leadership experience managing cross-functional and/or senior project teams ; Demonstrated success in strategy development and execution in both clinical research and clinical development environments ; Strong knowledge of the drug development process, GCP/ICH guidelines, and relevant regulatory requirements ; Significant operational experience in the planning, delivery, and oversight of clinical trials and regulatory submissions ; Budgetary, resource, and risk management expertise on a global or regional scale ; Exceptional written and verbal communication skills and ability to present to diverse stakeholder s; Demonstrated ability to mentor, develop, and lead teams ; Highly skilled in stakeholder engagement, negotiation, strategic influencing, and cross-functional collaboration ; Commitment to compliance and safety, health, and environmental standards ; Ability and willingness to travel nationally and internationally as required Desirable : Experience as a recognized expert or thought leader within the business and wider industry ; Project management certification or formal training ; Experience in the introduction or implementation of new technologies or innovative approaches within clinical research or development ; Experience in change management and process improvement initiatives ; Experience managing complex organizational structures or leading in a global organizational context ; Extensive familiarity with key therapeutic areas relevant to AstraZeneca’s portfolio ; Record of effective succession planning and leadership development within multi-level teams ; Experience in successful regulatory defense and participation in external advisory boards or similar expert panels ; Advanced negotiation and contracting experience with CROs or external service providers ; Ability to identify and leverage emerging trends in drug develop