Executive Director, Clinical Development Operations (Early Oncology)

Responsibilities

• 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.
• 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.
• Digital, Automation and AI Proficiency: Deep 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 optimiz e 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 rec

Benefits

Additional Information

Executive Director, Clinical Development Operations (Early Oncology) The Executive Director, Clinical Operations, is a transformative leader charged with setting the strategic direction, operational excellence, and future vision for Early Oncology (EO) clinical programs within the Clinical Programs & Study Operations (CPSO) organization. This role is at the helm of global clinical delivery, integrating advanced modalities, artificial intelligence, and digital innovation to redefine clinical trial operations. The Executive Director is responsible for overseeing a significant portion of the EO portfolio with full accountability for strategy, execution, resource optimization, and compliance.

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