Associate Director, Pediatric Clinical Research — Cancer Institute

About The Role

The Associate Director of Pediatric Clinical Research serves as the senior operational and execution leader for all pediatric cancer clinical research activities within the Cancer Center — spanning early phase (Phase I / first-in-child), investigator-initiated, cooperative group, and sponsor-driven trials supported by the CORKK and Cancer Center grant portfolio.

• Location
• Miami, Florida

About The Role

The Associate Director of Pediatric Clinical Research serves as the senior operational and execution leader for all pediatric cancer clinical research activities within the Cancer Center — spanning early phase (Phase I / first-in-child), investigator-initiated, cooperative group, and sponsor-driven trials supported by the CORKK and Cancer Center grant portfolio.

This role owns end-to-end program execution, ensuring that clinical research strategy, operations, regulatory compliance, workforce planning, and grant deliverables are aligned, resourced, and delivered on time.

The Associate Director provides non-clinical executive leadership, translating Cancer Center and physician-led scientific priorities into structured, compliant, and scalable research programs — with oversight of protocol development, translational integration, data interpretation, regulatory documentation, and dissemination of findings.

Key Responsibilities

• Strategic & Operational Leadership
• Provide overall leadership, oversight, and accountability for pediatric clinical research operations across the Cancer Center.
• Ensure full alignment between Cancer Center strategy, CORKK grant objectives, physician leadership priorities, and operational execution.
• Serve as the primary operational counterpart to executive leadership for pediatric cancer research.
• Clinical Trial Execution
• Direct all aspects of clinical research execution: study activation and startup timelines, portfolio management, prioritization, accrual performance and risk mitigation, and resource allocation and operational readiness.
• Oversee coordination among Clinical Trials Operations, Regulatory Affairs, Pharmacy, Biostatistics, and Translational Science teams.
• Implement systems, workflows, and governance structures to support high-complexity early-phase pediatric oncology trials.
• Regulatory & Compliance
• Ensure institutional compliance with GCP, FDA, IRB, sponsor, and grant requirements.
• Oversee regulatory strategy, audit preparedness, corrective actions, and quality improvement initiatives.
• Partner with Legal, Compliance, and OSP to manage regulatory risk across the portfolio.
• Grant & Financial Oversight
• Own operational delivery of CORKK and Cancer Center grant milestones, metrics, and reporting requirements.
• Oversee preparation of progress reports, dashboards, and documentation for internal leadership and external funders.
• Partner with Research Institute and Cancer Center leadership on resource planning, staffing models, and budget oversight.
• Ensure sustainability planning and alignment between grant scope, staffing models, and future funding strategies.
• Team & Workforce Leadership
• Lead workforce planning, organizational structure, and role alignment for pediatric cancer research teams.
• Oversee hiring, onboarding, training, and performance management of research leadership and operational staff.
• Build a culture of accountability, collaboration, and continuous improvement.
• External Representation
• Represent the Cancer Center’s pediatric research operations internally and with external partners.
• Support statewide and multi-institutional collaborations tied to Cancer Center growth.
• Serve as a key operational liaison to sponsors, partners, and collaborative research networks.

Qualifications

• Minimum Requirements
• MD, Ph D (Clinical Translational Science), or equivalent doctoral degree in Molecular Pharmacology, Biomedical Science, or a related field.

Doctor of Medicine candidates must hold board certification (unrestricted Florida medical license or eligibility).

• 8–10 years of experience in each of the following

• Advanced knowledge of drug development pathways, IND-driven research, FDA regulatory requirements, and Good Clinical Practice (GCP).
• Overseeing large, complex, multidisciplinary clinical research portfolios, including early phase, investigator-initiated, cooperative group, or sponsor-driven trials.
• Managing enterprise-level clinical research execution — study activation, operational workflows, accrual management, and portfolio prioritization.
• Supporting grant-funded research programs, including delivery of milestones, performance metrics, and reporting requirements.
• Working within regulatory and compliance frameworks, including IRB oversight, GCP, sponsor requirements, and FDA-adjacent research processes (clinical licensure not required).
• Partnering with physician leadership to translate scientific priorities into executable operational plans.
• Supervising research operations teams, program managers, or senior research staff.
• Working cross-functionally with Regulatory Affairs, Clinical Trials Operations, Pharmacy, Biostatistics, Translational Science, Finance, and Sponsored Programs.
• Preferred Knowledge, Skills & Abilities
• Experience in pediatric oncology, rare disease research, or other high-complexity therapeutic areas.
• Operational and governance experience supporting early-phase (Phase I / first-in-child) clinical trials.
• Experience with statewide, multi-institutional, or consortium-based research collaborations.
• Prior responsibility for grant governance, sustainability planning, or expansion of research programs beyond initial funding periods.
• Experience developing or implementing research performance dashboards, KPIs, or continuous quality improvement initiatives.
• Background in translational or correlative science programs, including integration with clinical trial operations.
• Progressively responsible leadership experience in clinical research operations, ideally within an academic medical center, cancer center, or complex healthcare research environment.
• Advanced understanding of early-phase clinical trials, operational risk, and regulatory execution.
• Proven ability to translate physician-led scientific strategy into executable, compliant operational plans.
• Demonstrated leadership in grant-funded research program management, performance tracking, and reporting.
• Exceptional organizational and systems-thinking skills across multi-departmental research environments.
• Ability to mentor and develop physician investigators and clinical scientist faculty along academic and research career paths.
• Demonstrated skills in strategic program development — portfolio growth, accrual optimization, statewide or multi-institutional collaboration.
• Strong executive presence and communication skills, including leadership-level reporting.
• Ability to manage competing priorities while maintaining rigor, quality, and accountability.
• Deadline to apply
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