Medical Director, Pediatric Early Phase Clinical Trials

Job Summary

The Medical Director provides strategic clinical and operational leadership for the Nicklaus Childrens Health System (NCHS) Pediatric Early Phase (Phase I/firstinchild) 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 earlyphase portfolio while advancing innovative therapeutics for children and adolescents with highrisk or refractory malignancies. The role expands the hospitals earlyphase clinical trials portfolio develops statewide referral networks and strategic partnerships and positions NCHS as a regional and national leader in pediatric earlyphase oncology research.

Job Specific Duties

• Provides strategic clinical and operational leadership for the Pediatric Early Phase (Phase I/firstinchild) 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 earlyphase 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 earlyphase 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 peerreviewed 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.

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.