Clinical Research & Development Director

What You Will Do

Externally recognized as a thought leader with deepexpertisein both clinical research and development with deep understanding of autoimmune disease, specifically inflammatory myopathies,JIAand/or Sjogren’s disease. Knowledge andexpertisein cell therapy is a plus.

Drivethe 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.

• Develop and align strategies andobjectivesfor 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 toidentifyresource need and secure resources to ensure flexible andtimelyformation 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 activelyparticipatesin 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.

• 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 stakeholders;
  
  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…