Sr Dir, ClinTrials Strat/Ops

Position Summary

The Senior Director, Clinical Trials Strategy and Operations will provide operational and programmatic leadership to advance a high-performing, institution-wide clinical trials strategy; support development and scaling of clinical trial services; improve study activation and execution; expand access to impactful trials; optimize the clinical trial portfolio and accrual, especially industry and/or foundation supported studies.

Responsibilities

• Strategic Leadership
• Develop and execute a multi-year strategy to strengthen clinical trials infrastructure, accelerate trial activation, increase accrual and expand non-federal and federal funding.
• Translate clinical trials priorities into actionable operating plans, timelines, staffing models and measurable outcomes.
• Establish and operationalize a governance structure for clinical trials that engages faculty, staff and institutional stakeholders in shared planning, prioritization and continuous improvement.
• Collaborate with research leadership to identify and expand/launch new multidisciplinary and cross-departmental clinical trial units.
• Support the Vice Dean for Clinical Trials as a senior institutional representative on committees overseeing clinical research strategy, ethics, and operations.
• Operational Excellence & Team Management
• Work with clinical research leadership to develop and oversee a multidisciplinary team providing clinical informatics, operations, and regulatory support.
• Oversee the recruitment, mentoring, and development of clinical research professionals, fostering collaboration, accountability, and professional growth.
• Establish performance metrics, dashboards, and continuous improvement initiatives to simplify, evaluate and monitor study start-up, workflows, trial feasibility, protocol support, and study coordination models.
• Identify pain points across the clinical trial lifecycle and lead solutions in collaboration with research offices, IRB/regulatory partners, contracting, and clinical operations teams.
• Develop standardized tools, templates, guidance, and service models to support trial quality, prioritization, and operational consistency.
• Evaluate and operationalize innovative tools and technologies that improve trial matching, recruitment, workflow integration, metrics reporting, and investigator experience.
• Support expansion of services such as protocol writing, PI concierge support, research staffing models, and shared resource approaches, in collaboration with Irving Institute and Cancer Center Research Navigation.
• Clinical Trials Infrastructure
• Build and scale shared services that support departments and clinical trial hubs.
• Partner with clinical and research leaders to expand trial activity across priority areas and new care settings.
• Support development of a “float pool” or other flexible staffing models for coordinators, research nurses, and specialized support staff.
• Foster collaboration across departments to adapt successful practices from established hubs and spread them across the enterprise.
• Lead initiatives to increase enrollment to scientifically impactful and medically meaningful trials.
• Collaborate with investigators, informatics, communications, and operational leaders to improve patient identification, outreach, recruitment, and retention.
• Help expand access to trials through innovative care models, including virtual and regionalized approaches where appropriate.
• Partnerships & External Engagement
• Build and maintain strategic relationships with industry partners (pharmaceutical, biotechnology, device sponsors), government agencies, and academic collaborators to advance research opportunities and institutional visibility.
• Serve as a point of contact for the Vice Dean of Clinical Trials with the Columbia Clinical Trials Office in the facilitating efficient contract and budget negotiations with sponsors, and revenue collection.
• Contribute to recharge, margin, and sustainability planning for centralized clinical trial services.

Minimum Qualifications

• Bachelor's degree or equivalent in and experience, plus 5 years of related experience
• Leadership experience in clinical trials, including in the pharmaceutical, biotechnology, medical device, or CRO industry, and/or large academic research environment
• Expertise in navigating FDA and EMA-regulated research as well as Good Clinical Practice (GCP) guidelines, HIPAA, IRB and other regulatory and compliance activities
• Demonstrated success designing and implementing clinical research strategies that drive innovation, operational improvements, and portfolio diversification
• Prominent track record in fostering cross-functional collaboration among research, clinical, and operational teams
• Must possess a customer-service orientation, with the ability to interact and collaborate positively, constructively and effectively with multiple executive level stakeholders
• Strong commitment to fostering diversity and equity

Preferred Qualifications

• Advanced degree (e.g., PhD, MD, PharmD, MBA, or equivalent) in a relevant scientific, clinical, or research discipline
• Established network within industry, regulatory bodies, and academic clinical research leaders
• Strong business acumen with experience in contract and budget negotiation, and external partnership development
• Experience with commercial E-Systems supporting clinical trial operations including Clinical Trial Management Systems (CTMS), Electronic Health Records (EHR), Electronic Data Capturing systems (EDCs), Velos, REDCap, LabArchives, and/or others
• Supervisory experience and strong interpersonal and team-building skills
• Bilingual (English, Spanish)