AstraZeneca

Executive Director, Clinical Development Operations (Early Oncology)

$284K–$427KFull-time · US - Gaithersburg - MD
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Senior · 10+ yrs exp

Requirements

Education: Bachelor's degree

Experience: 10+ years

Skills & tools

Team LeadershipOperationsCapital AllocationProject ManagementManagementMachine LearningTalent ManagementData Analysis

Benefits — mentioned in this posting

Bonus / commission
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Full job description

Key Responsibilities
  • Strategic Portfolio Leadership: Provide global oversight for significant portion of EO clinical portfolio, guiding project planning, operational delivery, and resource allocation to Global and Clinical Project Teams (GPTs/CPTs). Maintain continuity and minimize disruption through agile management of modality and indication groups, adapting responsively to the evolving clinical landscape.
  • Thought Leadership & Innovation: Consistently embrace novel operational models, platform studies, and customized strategies for complex modalities. Commission and implement AI/digital solutions and monitor industry innovations to ensure the organization remains at the cutting edge of clinical execution.
  • Regulatory & Compliance Stewardship: Anticipate and address emerging regulatory requirements, such as IVDR, by embedding compliance into operational strategy and process optimization. Collaborate cross-functionally to share best practices and harmonize quality standards.
  • Technology Transformation: Champion the deployment and integration of artificial intelligence, digital tools, and process automation across all clinical operations—accelerating cycle times, enhancing decision-making, and amplifying productivity. Collaborate with IT and digital partners for the continual development and deployment of future-focused solutions.
  • Collaborative Excellence: Foster strong cross-functional and external partnerships, engaging with Tumour Councils, Late Development Oncology (LDO) teams, vendors, and industry thought leaders. Support project handovers and drive shared accountability for study outcomes.
  • Talent Development & Inclusive Leadership: Build, inspire, and mentor high-performing, diverse teams—directly leading 8-10 Sr. Directors and indirectly overseeing 15-20 Study Leaders. Cultivate a pipeline for future leadership within a supportive environment.
  • Operational Best Practice: Establish and refine operational frameworks, leveraging AI and analytics to monitor performance, optimize site selection, and accelerate study start-up, close-out, and patient engagement. Drive continuous improvement through process excellence and data-driven insights.
  • Vendor & Resource Management: Lead strategic vendor engagement and procurement, ensuring effective collaboration with key delivery partners. Oversee resource alignment to support trial delivery needs and evolving project demands.
  • Quality Oversight & Process Enhancement: Set and uphold target metrics for clinical quality; oversee compliance and process improvement initiatives in partnership with Senior Director, Process and Execution Excellence and relevant Quality roles.
Key Competencies
  • Bachelor degree (MSc or PhD are highly desired) and over 10 years of combined experience in managing clinical programs (early oncology experience preferred)
  • Strategic Leadership: Visionary, forward-thinking, and adept at navigating complex, fast-paced environments.
  • Operational Excellence: Track record of delivering high-quality, timely, and cost-effective clinical operations.
  • Inclusive Team Development: Commitment to building diverse, talented, and resilient teams through coaching, mentoring, and succession planning.
  • Good understanding of how digital and AI technologies can unlock significant efficiencies for clinical trial execution.
  • Vendor Management: Expertise in partnering with alliance management, procurement, and SMEs to optimize vendor performance.
  • Change Leadership: Ability to inspire and mobilize teams to lead change within a dynamic clinical operations ecosystem.
  • Cross-functional Collaboration: Outstanding skills in stakeholder engagement, internal and external partnership, and consensus building.
  • Innovative Mindset: Adopts industry trends and pioneers new approaches in clinical trial design, delivery, and patient engagement.
  • Impact and Opportunities

  • Accelerate EO clinical execution by redefining processes, employing real-time analytics, and embedding AI at every stage of the study lifecycle.
  • Shape the future of clinical operations, setting new industry standards for speed, quality, and innovation.
  • Champion a culture of collaboration, inclusivity, and continuous learning.
  • Drive strategic initiatives that enhance patient recruitment, site engagement, and data integrity.
  • Secure operational readiness for the transition to Phase 3 delivery, ensuring seamless integration with late oncology team and maximizing clinical impact.

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