Clinical Research & Development Director

AstraZeneca • Gaithersburg, MD

1d

About The Position

This role requires an individual to be externally recognized as a thought leader with deep expertise in both clinical research and development, specifically in autoimmune disease, inflammatory myopathies, JIA, and/or Sjogren’s disease. Knowledge and expertise in cell therapy is a plus. The Director will drive the integrated clinical research and development strategy and execution to ensure value creation and regulatory/market success through innovative, cross-functional leadership. The role operates independently and at scale, influencing both operational excellence and strategic direction at the highest organizational levels.

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 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.

Nice To Haves

• 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.
• Knowledge and expertise in cell therapy.

Responsibilities

• 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.

Benefits

• Equal employment opportunities are available to all applicants and employees.

What This Job Offers

• Job Type: Full-time
• Career Level: Director