Clinical Research & Development Director

AstraZeneca; Gaithersburg (MD); On-site; USD 180,000 - 240,000; Full time

Job summary

AstraZeneca in the United States is seeking a senior leader to drive integrated clinical research and development strategies across autoimmune diseases. You will lead cross-functional teams, shape regulatory submissions, and ensure scientific rigor throughout the drug lifecycle.

The role requires an advanced degree and extensive expertise in clinical research and development, with strong stakeholder engagement, risk management, and global trial delivery experience.

Qualifications

• Advanced degree in a scientific or medical discipline.
• Extensive clinical research and development experience in pharma/biotech.
• Proven leadership of cross-functional and senior teams.
• Strong knowledge of drug development, GCP/ICH, and regulatory requirements.
• Experience with global/regional trial delivery, budgeting, and risk management.

Responsibilities

• Lead clinical research and development strategy and execution.
• Oversee CRO contracts, budgeting, timelines, and risk management.
• Mentor line managers and project teams; drive collaboration.
• Ensure compliance with Safety, Health, Environment, and regulatory guidelines.
• Engage stakeholders and drive strategic influencing across functions.

Skills

Advanced leadership

Clinical research

Clinical development

GCP/ICH knowledge

Regulatory submissions

Budgeting & risk mgmt

Stakeholder engagement

Travel willingness

Education

Master's/PhD in scientific/medical field

Job description

What You Will Do

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 elevate 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

Date Posted
09-Aug-2026

Closing Date
03-Sep-2026

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.