Associate Director, Pediatric Clinical Research - Cancer Institute
Oncology Voice Network · Pinecrest, FL · 2 wk ago
HealthcareFull-time
About the Role
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. This role is accountable for end-to-end program execution, ensuring alignment of clinical research strategy, operations, regulatory compliance, workforce planning, and grant deliverables. The position provides nonclinical executive leadership, translating Cancer Center and physician-led scientific priorities into structured, compliant, and scalable research programs.
Responsibilities
- Provides overall leadership, oversight, and accountability for pediatric clinical research operations across the Cancer Center, ensuring alignment between strategy, grant objectives, 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.
- Manages regulatory risk in collaboration with Legal, Compliance, and OSP.
- 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.
- Leads workforce planning, organizational structure, and role alignment for pediatric cancer research teams, including hiring, onboarding, training, and performance management.
- Builds a culture of accountability, collaboration, and continuous improvement.
- Represents the Cancer Center’s pediatric research operations internally and with external partners, supporting statewide and multi-institutional collaborations.
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.
- 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.
Skills
- 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.
- 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.
Location: Pinecrest, FL
Job Status: Professional