Clinical Research & Development Director
About the role
Externally recognized as a thought leader with deep expertise in both clinical research and development, specifically in autoimmune disease such as inflammatory myopathies, JIA, and/or Sjögren’s disease. Knowledge and expertise in cell therapy is a plus. You will 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.
Responsibilities
- Develop and align strategies and objectives for Clinical Research & Development, ensuring they support 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.
- Collaborate with Line Managers to identify resource needs and secure resources for flexible and timely formation of Clinical Research & Development Teams.
- Provide strategic and operational input to implement 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 participate in regulatory defense/approval processes.
- Foster 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 succession planning.
- Ensure all work complies with internal and external standards, including Safety, Health, Environment, and regulatory guidelines.
Requirements
- 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 clinical research and 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.
Preferred Qualifications
- 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 development, technology, and scientific innovation.
Key Relationships
Internal: Study Delivery personnel; Data Management Centre representatives; Clinical Project Team and therapy area personnel; Clinical Development personnel; Clinical Pharmacology Units; Study Site personnel; Regional Monitoring personnel; Other Skill Centres as appropriate.
External: External service providers; Investigators and scientists; Patient advocacy groups; External Alliance partners.
Date Posted: 09-Aug-2026 | Closing Date: 03-Sep-2026