Clinical Research & Development Director

Thought Leader In Clinical Research And Development

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 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 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 Relationship to Reach Solutions

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 and patient advocacy groups; and external Alliance partners