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 and 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, PhD (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.

How to Apply

Apply and learn more at: careers.nicklaushealth.org — Associate Director, Pediatric Clinical Research

Deadline to apply: October 20, 2026