Sr Dir, ClinTrials Strat/Ops

• Job Type: Officer of Administration
• Bargaining Unit:
• Regular/Temporary: Regular
• End Date if Temporary:
• Hours Per Week:
• Standard Work Schedule:
• Building:
• Salary Range: $175,000-$225,000

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.

Working in close partnership with institutional leaders, the Senior Director/Director will lead cross-functional initiatives that reduce barriers for investigators, standardize best practices and support emerging and existing trials hubs.  The Senior Director/Director work with a multidisciplinary team responsible for coordinating clinical trials initiatives. The ideal candidate will have significant clinical trials and industry/pharmaceutical/biotech/CRO experience.

Reporting: The Senior Director/Director will report to the VP&S Vice Dean for Clinical Trials and will work closely with the Irving Institute and VP&S research leadership, department chairs, principal investigators, and leaders across research administration, regulatory and contracting (including Columbia Executive Vice President for Research (EVPR) and its Clinical Trials Office (CTO)), informatics, communications, and finance.

Responsibilities

Strategic Leadership

• Working with the Vice Dean for Clinical Trials, 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.
• Help 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.
• Support portfolio management approaches that assess trial performance, accrual, activation timelines, and operational burden.
• 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.
• Proven 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).

Equal Opportunity Employer / Disability / Veteran

Columbia University is committed to the hiring of qualified local residents.