Associate Director, Pediatric Clinical Research (MD/DO) - Cancer Institute

Nicklaus Children's Hospital•Miami, FL

About The Position

The Associate Director of Pediatric Clinical Research serves as the senior operational and execution leader for pediatric cancer clinical research activities within the Cancer Center. The portfolio includes early-phase trials, including Phase I and first-in-child studies, investigator-initiated studies, cooperative group trials, and sponsor-driven trials supported by the CORKK and Cancer Center grant portfolio. The role provides nonclinical executive leadership, translating Cancer Center and physician-led scientific priorities into structured, compliant, and scalable research programs. It is accountable for end-to-end program execution, ensuring that research strategy, operations, regulatory compliance, workforce planning, and grant deliverables are aligned, appropriately resourced, and delivered on time. The position also provides oversight and scientific direction in protocol development, translational integration, data interpretation, regulatory documentation, and dissemination of research findings, while retaining responsibility for operations, performance, governance, and program execution.

Requirements

MD, PhD (Clinical Translational Science), or equivalent doctoral degree in Molecular Pharmacology, Biomedical Science, or a related field.
For a physician, Doctor of Medicine with board certification and an unrestricted Florida medical license or eligibility.
8–10 years of advanced knowledge of drug development pathways, IND-driven research, FDA regulatory requirements, and Good Clinical Practice (GCP).
8–10 years of experience overseeing large, complex, multidisciplinary clinical research portfolios, including early-phase, investigator-initiated, cooperative group, or sponsor-driven trials.
8–10 years of experience managing enterprise-level clinical research execution, including study activation, operational workflows, accrual management, and portfolio prioritization.
8–10 years of experience supporting grant-funded research programs, including delivery of milestones, performance metrics, and reporting requirements.
8–10 years of experience working with regulatory and compliance frameworks, including IRB oversight, GCP, sponsor requirements, and FDA-adjacent research processes; clinical licensure is not required for this experience.
8–10 years of experience partnering with physician leadership to translate scientific priorities into executable operational plans.
8–10 years of leadership experience supervising research operations teams, program managers, or senior research staff.
8–10 years of experience working cross-functionally with Regulatory Affairs, Clinical Trials Operations, Pharmacy, Biostatistics, Translational Science, Finance, and Sponsored Programs.
Deep expertise in research operations, particularly in pediatric oncology or high-complexity research environments.
Progressively responsible leadership experience in clinical research operations, preferably within an academic medical center, cancer center, or complex healthcare research environment.
Advanced understanding of early-phase clinical trials, operational risk, and regulatory execution; clinical licensure is not required for this understanding.
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, including portfolio growth, accrual optimization, and 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.

Nice To Haves

Experience in pediatric oncology clinical research, rare disease research, or high-complexity therapeutic areas.
Experience supporting early-phase (Phase I/first-in-child) clinical trials from an operational and governance perspective.
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 working with translational or correlative science programs, including integration with clinical trial operations.

Responsibilities

Provide overall leadership, oversight, and accountability for pediatric clinical research operations across the Cancer Center.
Align 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.
Direct study activation and startup timelines, portfolio management and prioritization, accrual performance and risk mitigation, 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 complex early-phase pediatric oncology trials.
Ensure institutional compliance with GCP, FDA, IRB, sponsor, and grant requirements.
Oversee regulatory strategy, audit preparedness, corrective actions, and quality improvement initiatives.
Partner with Research Institute and Cancer Center leadership on resource planning, staffing models, and budget oversight for early-phase research.
Partner with Legal, Compliance, and OSP to manage regulatory risk across the portfolio.
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.
Ensure sustainability planning and alignment among grant scope, staffing models, and future funding strategies.
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.
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.
Provide oversight and scientific direction in protocol development, translational integration, data interpretation, regulatory documentation, and dissemination of research findings.