Associate Director, Pediatric Clinical Research - Cancer Institute

Description

Job Summary

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.

Job Specific Duties

• 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. 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.
• Serves as a key operational liaison to sponsors, partners, and collaborative research networks

Qualifications

Minimum Job 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.

Knowledge, Skills, and Abilities

• Experience in pediatric oncology clinical research, rare disease research, or high complexity…