Medical Director, Pediatric Early Phase Clinical Trials

Description

Job Summary

The Medical Director provides strategic, clinical, and operational leadership for the Nicklaus Children’s Health System (NCHS) Pediatric Early Phase (Phase I/first-in-child) Oncology Clinical Trials Program within the Phase I Clinical Trials Unit. This physician leader is responsible for the scientific integrity, regulatory oversight, patient safety, and growth of the early-phase portfolio while advancing innovative therapeutics for children and adolescents with high-risk or refractory malignancies. The role expands the hospital’s early-phase clinical trials portfolio, develops statewide referral networks and strategic partnerships, and positions NCHS as a regional and national leader in pediatric early-phase oncology research.

Job Specific Duties

• Provides strategic, clinical, and operational leadership for the Pediatric Early Phase (Phase I/first-in-child) Oncology Clinical Trials Program within the Phase I Clinical Trials Unit.
• Serves as Principal Investigator on investigator initiated and industry-sponsored FIH/Phase I oncology trials. 
• Provides operational oversight, leadership, and direction in the execution and management of early phase clinical trials; focuses on creating a robust early phase clinical trial; focuses on creating a robust early phase clinical trial portfolio supporting the NCHS patient population and furthering scientific and clinical recovery. 
• Leads protocol development, safety monitoring, toxicity management, and DSMB reporting for early-phase studies.
• Ensures integration of translational science, biomarker strategies, and precision oncology approaches. 
• Monitors patient accrual rates and implements action plans for accrual issues. 
• Oversees IND submissions and FDA communications, ensuring compliance with federal, state, and institutional regulatory requirements and rigorous pharmacovigilance standards.
• Expands the early-phase clinical trials portfolio at NCHS and develops statewide referral networks to improve trial access and enrollment. 
• Builds strategic partnerships with academic institutions, biotech/pharma sponsors, federal agencies, and statewide collaborative partners. 
• Provides mentorship of physicians on Clinical Scientist track or Translational Scientist track.
• In partnership with the Director of Research and in collaboration with the Cancer Institute dyad team, identifies and communicates strategic research initiatives and growth of research portfolio.
• Partners with Executive Director of the Research Institute in identification of research needs and review of requests for research personnel, equipment, and other resources. 
• Partners with the Executive Director of the Research Institute to provide oversight for clinical research nurses, coordinators, regulatory staff, and data teams. 
• Participates in the Research Institute feasibility review process for all pending early phase clinical research studies; in partnership with the Executive Director of Research, reviews research activity budgets, identifies, and communicates adjustments as necessary. 
• Leads quality assurance and continuous improvement initiatives. 
• Maintains an active clinical practice in pediatric oncology and ensures the highest standards of patient care within the trials program. 
• Publishes peer-reviewed research, presents nationally, mentors junior faculty, fellows, and research staff, and contributes to grant development and extramural funding efforts
• Early-phase oncology clinical trials leadership: Demonstrated leadership experience in early-phase (Phase I) oncology clinical trials and service as Principal Investigator on oncology trials. 
• Clinical practice in pediatric hematology/oncology: Experience providing clinical care for children and adolescents with cancer in a tertiary or quaternary pediatric setting. 

Qualifications

Minimum Job Requirements

• MD OR DO Board-certified in Pediatric Hematology/Oncology from an accredited residency/fellowship program. 
• Florida Medical License: Unrestricted license to practice medicine in the State of Florida.
• Board Certification in Pediatric Hematology/Oncology by an appropriate ABMS board. 

Knowledge, Skills, and Abilities

• Strategic vision and program-building expertise in pediatric oncology and clinical trials.
• Advanced clinical judgement in high-acutiy pediatric oncology care and early-phase trial decision-making. 
• Deep regulatory and compliance expertise, including IND submissions, FDA communication. and pharmacovigilance.
• Collaborative leadership and stakeholder engagement skills across clinicians, research staff, administration, and external partners. 
• Commitment to health equity and access, including improving trial availability for diverse patient populations. 
• Strong communication, mentorship, and change-management skills suitable for leadership role.  

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