Executive Director, Clinical Development Operations (Early Oncology)

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. 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. Commitment to Inclusion & Excellence The Executive Director, GCL H Clinical Operations, is committed to fostering an environment where every team member can thrive. This role actively promotes diversity, equity, and inclusion, recognizing that the power of varied perspectives drives transformative progress in clinical research. The annual base pay for this position ranges from $ 284,381 - 426,572 USD. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.Date Posted07-Aug-2026Closing Date30-Aug-2026Our 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.SummaryLocation: US - Gaithersburg - MD; US - Boston - MAType: Full time