Medical Director, Pediatric Early Phase Clinical Trials

Nicklaus Children's Hospital•Miami, FL

About The Position

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.

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.
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.

Nice To Haves

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.

Responsibilities

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