Director of Clinical Operations

Director of Clinical OperationsOnsite - Miami Lakes, Florida 33016M-F 9-5PM ESTClinical Research: Conducting Phase I-IV research trials with a primary emphasis on psychiatry, neurology, addiction, insomnia, general medicinePrior experience as a Clinical Research Coordinator required.Summary:The Director of Clinical Operations leads operations across all current clinical sites, and future sites to ensure that Trials operational and financial objectives are met. The individual in this position is directly accountable to ensure the following targets are met: enrollment goals, compliance standards, clinical trial milestones, study and site budgets, company profitability, revenue goals and staff retention.Additional accountabilities include clinical quality of care, patient satisfaction, client satisfaction, productivity, revenue enhancement and staff leadership. The individual in this role will have a physical presence at each of our sites, supporting directors, solving problems in real-time, and driving site-level performance. This person should bring a deep understanding of site operations, financial analytics, and organizational leadership, with a proven track record of growing clinical sites and optimizing team performance.Duties and Responsibilities:Strategic & Financial PlanningCollaborates in the development and implementation of the company's long-range strategic operational plan ensuring it is consistent with the overall master plan.Develops, plans, and participates in the implementation of departmental and site goals by actively participating in strategic planning and goals setting activities.Initiates and recommends actions to accomplish these objectives. Evaluates and makes recommendations towards enhancing or improving the company's strategic plan, performance measures, and initiatives to improve effectiveness.Monitors financial (revenue and profit) key performance indicators on an ongoing basis, investigates budget variances, and adjusts operations or recommends adjustments, as necessary.Develop department and site annual budgets (operational and capital) on a timely basis.Works closely with the Director of Finance and Business Operations to establish financial reporting systems and controls to ensure compliance with company expenditure requirements while meeting operational demands.Reviews individual needs of each site for expansion and restructuring.Organizes and implements layouts for construction development or expansion into new sites.Collaborates with business development, patient recruitment and M & A leadership to drive organic and new growth within market targets.Clinical Expertise:Provides direct oversight and management of Clinical Operations leaders involved in clinical trial execution and other functional groups as assigned.Implements a strong quality culture within Clinical Operations ensuring all clinical trials are conducted according to ICH/GCP requirements, corporate/departmental SOPs/ policies, and industry best practices.Provides operational and clinical expertise and strategic insights to assist partner companies develop strategy, design, and methodology of clinical development programs.Provides strategic and tactical guidance in risk management and anticipates/recognizes risks and issues on studies; oversees resolution and/or escalation of study related issues.Leads and executes initiatives to build clinical department infrastructure and to improve efficiency and effectiveness of processes and procedures. Contributes to development of SOPs.Ensures clinical trials are conducted in compliance with applicable regulatory requirements and are inspectionPeople LeadershipTranslates strategy into actionable goals for performance and growth, helping to implement company-wide goal setting.Oversees employee productivity, building a highly inclusive culture ensuring team members thrive through mentorship, orientation programs and educational opportunities.Helps develop KPI's, bonus structures and data driven performance metrics.Creates a positive and productive work environment to attract and retain staff, providers, and patients.Works collaboratively with other Directors, Managers and HR to address personnel issues. Key Performance Indicators Financial & Business PerformanceMonthly Revenue vs. Forecast (per site and network-wide)Cost per Visit / Study Profitability ReportsStudy Startup Timeline Adherence (% of sites hitting startup targets)Budget Finalization Timeliness (e.g., % of budgets finalized within 30 days of award)Protocol Deviations Tied to Operational Gaps (tracked and trended) Site Operations & CapacityActive Studies per Site (tracked against staffing capacity recommendations)Utilization Rate of Site Staff (time on protocol-related tasks vs. administrative work)Time from Feasibility to FPI (First Patient In)Percentage of Monitor Visits Completed Without Action ItemsProtocol Adherence Rate (site-specific and cumulative) People & Team AccountabilityQuarterly KPI Review Completion Rate (with Directors)Team Performance Improvement Plan (PIP) Follow-Through %Departmental Cross-Collaboration Score (measured via brief 360 evaluations)Site Visit Frequency (min. number of days spent per site/month) Growth & ExpansionNumber of New Sites or Expanded Capabilities Brought OnlineFeasibility Response Rate & Win Rate (% of awarded studies from responded feasibilities)Vendor or System Implementation Timeliness & Adoption ScoreQualifications:The successful candidate will be an innovative and collaborative individual who thrives in a "get it done" type of environment with diverse clinical operations experience and the following mix of personal and professional characteristics:Minimum B.A./B.S. degree in science/healthcare field or a nursing/psychiatry/psychology degree10+ years' experience of Clinical Operations experience at biotechnology or pharmaceutical company, site or CRO, with at least 5+ years of people managementDemonstrated strong coaching and mentoring skillsExperience working within psychiatry/women's health experience is a plusDetailed knowledge of GCP, ICH Guidelines and current US FDA regulationsBudget & financial managementClear and effective communication & diplomacy skillsExcellent leadership and interpersonal skills; ability to collaborate across disciplines with demonstrated ability to effectively lead multi-disciplinary global teamsAttention to detailAbility to multitaskTravel required to sites with the Miami-Dade, Broward, and Palm Beach County areasTravel out of state up to 10%

Created: 2025-09-26