Associate Director, Pediatric Clinical Research - Cancer Center

Nicklaus Children's•Miami, FL

About The Position

The Associate Director of Pediatric Clinical Research – Cancer Center, serves as the senior operational and execution leader for all pediatric cancer clinical research activities within the Cancer Center, including 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 is accountable for 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. Provides nonclinical executive leadership, translating Cancer Center and physician led scientific priorities into structured, compliant, and scalable research programs. 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 related field
Doctor of Medicine with board certification (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 extensive 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 (without requiring clinical licensure).
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.

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.
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 (without requiring clinical licensure).
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.

Responsibilities

Provides overall leadership, oversight, and accountability for pediatric clinical research operations across the Cancer Center.
Ensures full alignment between Cancer Center strategy, CORKK grant objectives, physician leadership priorities, and operational execution.
Serves as the primary operational counterpart to executive leadership for pediatric cancer research.
Directs all aspects of clinical research execution, including study activation and startup timelines, portfolio management and prioritization, accrual performance and risk mitigation, and resource allocation and operational readiness.
Oversees coordination among Clinical Trials Operations, Regulatory Affairs, Pharmacy, Biostatistics, and Translational Science teams.
Implements systems, workflows, and governance structures to support high complexity early phase pediatric oncology trials.
Ensures institutional compliance with GCP, FDA, IRB, sponsor, and grant requirements.
Oversees regulatory strategy, audit preparedness, corrective actions, and quality improvement initiatives.
Partners with Research Institute and Cancer Center leadership on resource planning, staffing models, and budget oversight for early phase research.
Partners with Legal, Compliance, and OSP to manage regulatory risk across the portfolio.
Owns operational delivery of CORKK and Cancer Center grant milestones, metrics, and reporting requirements.
Oversees preparation of progress reports, dashboards, and documentation for internal leadership and external funders.
Ensures sustainability planning and alignment between grant scope, staffing models, and future funding strategies.
Leads workforce planning, organizational structure, and role alignment for pediatric cancer research teams.
Oversees hiring, onboarding, training, and performance management of research leadership and operational staff.
Builds a culture of accountability, collaboration, and continuous improvement.
Represents the Cancer Center’s pediatric research operations internally and with external partners.
Supports statewide and multi institutional collaborations tied to Cancer Center growth.