Research And Development Jobs in Maryland (NOW HIRING)

What You Will Do

Externally recognized as a thought leader with deepexpertisein both clinical research and developmentwith deep understanding of autoimmune disease, specifically inflammatory myopathies,JIAand/or Sjogren’s disease. Knowledge andexpertisein cell therapy is a plus.Drivethe integrated clinical research and development strategy and execution,to ensurevalue 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.

• Develop and align strategies andobjectivesfor Clinical Research & Development, ensuring they support AstraZeneca’s global goals and product vision.
• Lead and overseeexecution 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 toidentifyresource need and secure resources to ensure flexible andtimelyformation 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 activelyparticipatesin regulatorydefense/approval processes.
• Has personal responsibility for creating a culture of courageous leadership,creativityand 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.

• 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-functionalcollaboration;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

• 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 SkillCentresas appropriate

• External:External service providers;Investigators and scientists and patient advocacy groups; and external Alliance partners

Date Posted

Closing Date

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