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

Nicklaus Children's Health System - Miami, FL

Hiring: Associate Director, Pediatric Clinical Research (MD/DO) - Cancer Institute Company: Nicklaus Children's Health System Location: Miami, FL Job Posted Time: 2026-09-14 14:55:04 Target Skills & Keywords : GCP, Portfolio Management, Program Management, Regulatory Compliance About the job Experience: •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). Required Skills: •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. Qualifications: •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) •Prior responsibility for grant governance, sustainability planning, or expansion of research programs beyond initial funding periods. •Background working with translational or correlative science programs, including integration with clinical trial operations. Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!