Senior Director, Clinical Trials Strategy and Operations

About the Role Senior-level leader responsible for developing and executing Columbia's institution-wide clinical trials strategy, scaling services, and optimizing trial activation, accrual, and portfolio management across hubs. Works in close partnership with institutional leaders to reduce barriers, standardize practices, and coordinate cross-departmental clinical trials initiatives. What You'll Do

• Develop and execute a multi-year clinical trials strategy with the Vice Dean for Clinical Trials to strengthen infrastructure, accelerate activation, increase accrual, and expand non-federal/federal funding.
• Translate priorities into actionable operating plans, timelines, staffing models, and measurable outcomes.
• Establish and operationalize a governance structure for clinical trials engaging faculty, staff, and institutional stakeholders in planning, prioritization, and continuous improvement.
• Collaborate with research leadership to identify and launch new multidisciplinary and cross-departmental trial units.
• Represent the role as a senior institutional lead on committees overseeing clinical research strategy, ethics, and operations.
• Oversee a multidisciplinary team providing clinical informatics, operations, and regulatory support; recruit, mentor, and develop clinical research professionals.
• Establish performance metrics, dashboards, and continuous-improvement initiatives to monitor study start-up, workflows, feasibility, protocol support, and study coordination models.
• Identify pain points across the trial lifecycle and lead cross-functional solutions with research offices, IRB/regulatory partners, contracting, and clinical operations.
• Develop standardized tools, templates, guidance, and service models to support trial quality and operational consistency; evaluate innovative tools to improve matching, recruitment, workflow, and investigator experience.
• Support expansion of services such as protocol writing, PI concierge support, research staffing models, and shared resources in collaboration with the Irving Institute and Cancer Center.
• Build and scale shared services to support departments and hubs; explore float pools or flexible staffing models for coordinators and specialized staff.
• Expand enrollment in scientifically meaningful trials and improve patient identification, outreach, recruitment, and retention through collaboration with informatics and operations.
• Implement portfolio management approaches that assess trial performance, accrual, activation timelines, and operational burden; advance access to trials via virtual or regionalized care models where appropriate.
• Build and maintain strategic relationships with industry sponsors, government agencies, and academic collaborators; coordinate contract and budget negotiations and revenue collection through the Columbia Clinical Trials Office.
• Contribute to recharge, margin, and sustainability planning for centralized clinical trial services. What We're Looking For
• Bachelor's degree; significant clinical trials experience across academia and/or industry (pharmaceutical/biotech/CRO).
• Demonstrated ability to lead cross-functional teams and strategic initiatives; experience serving on governance bodies related to clinical research strategy, ethics, and operations.
• Strong collaboration with leadership, investigators, and research administration; proficiency in coordinating regulatory, contracting, informatics, and finance aspects of trials.
• Excellent communication, program management, and change-management skills. Nice to Have
• Experience with trial hubs, centralized services, and informatics-enabled trial operations.
• Familiarity with protocol writing, PI concierge support, staffing models, and shared-resource approaches. Compensation & Benefits
• Salary Range: $175,000-$225,000 per year. The finalist salary will be set based on departmental budgets, qualifications, experience, education, licenses, specialty, and training. This range represents the University's good-faith and reasonable estimate of compensation at the time of posting.