Clinical Research & Development Director

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