New

DIRECTOR, CLINICAL TRIALS OPERATIONS, DCRI

Duke Clinical Research Institute
United States, North Carolina, Durham
300 West Morgan Street (Show on map)
Mar 04, 2026
School of Medicine Established in 1930, Duke University School of Medicine is the youngest of the nation's top medical schools. Ranked sixth among medical schools in the nation, the School takes pride in being an inclusive community of outstanding learners, investigators, clinicians, and staff where interdisciplinary collaboration is embraced and great ideas accelerate translation of fundamental scientific discoveries to improve human health locally and around the globe. Composed of more than 2,500 faculty physicians and researchers, more than 1,300 students, and more than 6,000 staff, the Duke University School of Medicine along with the Duke University School of Nursing, Duke University Health System and the Private Diagnostic Clinic (PDC) comprise Duke Health. a world-class academic medical center. The Health System encompasses Duke University Hospital, Duke Regional Hospital, Duke Raleigh Hospital, Duke Primary Care, Duke Home and Hospice, Duke Health and Wellness, and multiple affiliations. *Position Summary* Reporting to the Chief Operating Officer, the Director, Project Delivery serves as the senior leader responsible for the strategic oversight, operational excellence, and successful execution of a designated industry-sponsored clinical trial portfolio. This role provides executive-level project governance, ensures delivery to key performance metrics, and partners across the organization to optimize project outcomes, client satisfaction, and institutional growth. The Director serves as a key escalation point and governance lead for high-profile sponsors, while mentoring Project Leads and embedding best-in-class operational practices that strengthen DCRI's reputation as a premier academic research partner. NOTE: This position may have an opportunity to work remotely. All Duke University and Duke Health remote workers must reside in one of the following states or districts: Arizona; California; Florida; Georgia; Hawaii; Illinois; Maryland; Massachusetts; Montana; New Jersey; New York; North Carolina; Pennsylvania; South Carolina; Tennessee; Texas; Virginia or Washington, DC., Washington (State), Connecticut, Indiana, Michigan, Maine, Ohio, New Hampshire, Alabama, Kentucky, Louisiana, Oregon, Iowa, Missouri, Delaware, and Connecticut Primary Responsibilities and Task Strategic & Portfolio Governance Own sponsor-facing governance and portfolio-level accountability for assigned industry sponsors, including delivery performance, executive engagement, and proactive risk management. Provide executive-level oversight and governance of designated project portfolios for large industry sponsors, ensuring on-time, on-budget, and high-quality delivery Provide portfolio-level governance and relationship management for large industry sponsors, ensuring strategic alignment and proactive risk management Lead internal and external project governance activities (steering committee meetings, executive business reviews, portfolio performance discussions) Partner with Clinical Operations leadership to align portfolio delivery priorities and sponsor expectations with functional execution. Partner closely with Clinical Operations leadership to align resource planning, operational execution, and governance frameworks, ensuring seamless integration between project oversight and clinical delivery. Partner with COO and leadership to design and implement a therapeutically aligned Project Delivery structure as a proof-of-concept model for future scaling. Stakeholder Engagement & Relationship Management Maintain strong client and internal relationships Serve as key escalation point and relationship manager for large, high-profile industry sponsors Represent DCRI in professional and sponsor-facing forums to enhance visibility of DCRI's expertise and operational excellence Business Development & Strategic Alignment Collaborate with Business Development to support proposal strategy, bid defense participation, and pricing alignment Work closely with Business Development and Research Proposal Development teams to shape proposal strategy, validate operational feasibility, and ensure competitive positioning for new opportunities Act as the strategic connector between Business Development and Clinical Operations, bridging sponsor engagement, proposal development, and operational delivery Therapeutic & Functional Expertise Serve as a therapeutic area expert providing input into feasibility, protocol development, and operational strategy Interface with functional area heads (Clinical Operations, Biostatistics, Data Solutions, Regulatory, and Quality) to ensure resource alignment and operational consistency Operational Excellence & Project Performance Management Serve as primary escalation point for operational or strategic issues across assigned projects Partner with Project Leads to monitor project health, KPIs, risk management, and financial performance; drive corrective actions as needed Understand and manage both project-specific and functional KPIs in collaboration with Clinical Operations and sponsor expectations Establish clear escalation pathways and governance structures in collaboration with Sponsor and Clinical Operations leadership to manage risks and client escalations Translate industry trends and operational intelligence into actionable insights for continuous process and performance improvement Other Duties Performs other related duties incidental to the work described herein. Required Qualifications Education/Training: Work requires a Bachelor's degree. Advanced degree preferred (e.g., MSN, MPH, MHA, PharmD, MBA). Experience: Ten years of relevant experience to include 7 years in leadership roles. At least five years in a leadership or management capacity in the contract research, pharmaceutical, medical device, or biotechnology industry or in an academic research organization is preferred. Knowledge, Skills and Abilities: Proven ability to lead global, multi-site industry-sponsored studies within the cardiovascular therapeutic area. Strong operational and financial acumen, including P&L accountability, KPI management, and performance optimization. Demonstrated success in stakeholder engagement, client governance, and cross-functional leadership. Excellent communication, strategic thinking, and mentoring skills. Demonstrated commitment to diversity, equity, and inclusion in leadership and team development. Minimum Qualifications Education Work requires a Bachelor's degree Experience Ten years of relevant experience to include 7 years in leadership roles. OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE Degrees, Licensures, Certifications Ten years of relevant experience to include 7 years in leadership roles. OR AN EQUIVALENT COMBINATION OF RELEVANT EDUCATION AND/OR EXPERIENCE Duke is an Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex (including pregnancy and pregnancy related conditions), sexual orientation or military status. Duke aspires to create a community built on collaboration, innovation, creativity, and belonging. Our collective success depends on the robust exchange of ideas-an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values. Essential Physical Job Functions:** Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.