Associate Medical Director Pediatric Clinical Research - Cancer Institute

Nicklaus Children's Health System has an outstanding opportunity for an Associate Director of Pediatric Clinical Research - Cancer Institute in Miami, Florida.

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The Associate Director of Pediatric Clinical Research – Cancer Institute serves as senior operational leader for all pediatric cancer clinical research activities, including Phase I/first-in-child, investigator-initiated, cooperative group, and sponsor-driven trials in the CORKK and Cancer Institute grant portfolio. Accountable for end-to-end program execution, clinical research strategy, operations, regulatory compliance, workforce planning, and grant deliverables. Translates physician-led scientific priorities into compliant, scalable research programs. Oversees protocol development, translational integration, data interpretation, regulatory docs, and operations.

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Job Specific Duties

• Operations & Governance: Directs operations, study activation, portfolio management, accrual, and resource allocation across Clinical Trials Operations, Regulatory Affairs, Pharmacy, Biostatistics, and Translational Science teams.
• Compliance & Risk: Ensures GCP, FDA, IRB, sponsor, and grant compliance. Oversees regulatory strategy, audit prep, corrective actions, and quality improvement. Partners with Legal, Compliance, OSP, and Research Institute on risk, staffing, and budgets.
• Grant Management: Delivers CORKK and Cancer Institute grant milestones, metrics, and reporting. Oversees progress reports, dashboards, and long-term sustainability planning.
• Leadership & Strategy: Leads workforce planning, hiring, training, and performance management. Represents pediatric operations internally, statewide, and with multi-institutional partners and sponsors.

Minimum Requirements

• Education: MD, PhD (Clinical Translational Science), or equivalent doctoral degree in Molecular Pharmacology or Biomedical Science or related field. Doctor of Medicine with board certification (Unrestricted Florida Medical license or eligibility).
• Experience (8–10 years required in each):
• Advanced knowledge of drug development, IND-driven research, FDA requirements, and GCP.
• Overseeing large Phase I/first-in-child, investigator-initiated, cooperative, and sponsor trials in pediatric oncology or rare diseases.
• Enterprise research execution (study activation, workflows, accrual, portfolio prioritization).
• Supporting grant-funded programs (CORKK/equivalent) delivering milestones and reporting.
• Working with regulatory/compliance frameworks (IRB, GCP, FDA-adjacent processes without requiring clinical licensure).
• Partnering with physician leadership to translate scientific priorities into operational plans.
• Supervising research operations teams, program managers, or senior staff.
• Cross-functional collaboration with Regulatory, Operations, Pharmacy, Biostatistics, Translational Science, Finance, and OSP.

Knowledge, Skills, & Abilities

• Expertise in pediatric oncology, rare disease research, translational science, and research performance dashboards/KPIs.
• Deep experience in academic medical center research operations, grant governance, multi-institutional collaborations, and mentoring physician investigators/faculty.

About Nicklaus Children’s Health System

Founded in 1950 by Variety Clubs International, Nicklaus Children's Health System is South Florida's only licensed specialty hospital exclusively for children, with nearly 800 attending physicians and more than 475 pediatric sub-specialists. The 325-bed hospital, known as Miami Children's Health System from 1983 through 2014, is renowned for excellence in all aspects of pediatric medicine, with many programs routinely ranked among the nation's best by U.S. News & World Report, since 2008. The hospital is also home to the largest pediatric teaching program in the southeastern United States and has been designated an American Nurses Credentialing Center (ANCC) Magnet facility, the nursing profession's most prestigious institutional honor. The Nicklaus Children's Hospital network includes more than a dozen outpatient centers extending from Palm Beach County to southern Miami-Dade County, offering a range of pediatric healthcare services, including urgent care, rehabilitation services and subspecialty physician appointments for children of all ages, including up to age 21. We are committed to being a resource for children from throughout South Florida and around the world.