Jobs · Analyst · Maryland

Clinical Research & Development Director

AstraZeneca · Gaithersburg, MD · 2 wk ago
AnalystFull-time

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

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