Position Summary

The Medical Director – Late Phase Research provides senior clinical leadership and strategic oversight for all Late Phase clinical trials across Florida Cancer Specialists & Research Institute. This role ensures high‑quality medical governance, protocol adherence, operational excellence, and regulatory compliance for all Late Phase studies, while partnering closely with research operations, physicians, executive leadership, sponsors, and CROs.
The Medical Director plays a key role in expanding patient access to research, optimizing trial performance, and enhancing FCS’s scientific and clinical reputation in Late Phase oncology research.

Primary Responsibilities

Clinical Leadership & Governance

• Serve as the primary clinical leader for Late Phase research programs, providing oversight of study conduct, medical integrity, and patient safety.

• Review and interpret clinical protocols and ensure feasibility, quality, and compliance with GCP, FDA regulations, and institutional policies.

• Partner with Principal Investigators, research operations, and clinical teams to ensure appropriate patient eligibility, safety monitoring, and protocol deviations management.

Operational Oversight

• Collaborate with the Associate/Senior Directors of Late Phase Operations to ensure seamless study execution, timely start‑up, and high‑quality data.

• Support development and implementation of research Standard Operating Procedures (SOPs) and clinical workflows.

• Participate in performance monitoring of trial metrics including enrollment, timeliness, deviations, and data integrity.

Collaboration & Stakeholder Engagement

• Act as a key liaison with clinical investigators, research coordinators, operational leadership, and executive management to facilitate study success.

• Maintain collaborative relationships with pharmaceutical sponsors, CROs, and Institutional Review Boards (IRBs).

• Provide medical expertise during sponsor meetings, site visits, audits, and escalation discussions.

Strategic Program Development

• Contribute to institutional strategy for growth of the Late Phase research portfolio, ensuring alignment with organizational goals and scientific priorities.

• Evaluate emerging therapeutic areas and support feasibility assessments for new studies.

• Help maintain a robust and diverse portfolio of Late Phase clinical trials supporting patient access and innovation.

Education & Communication

• Educate physicians, APPs, and clinical research staff on Late Phase study requirements, protocol updates, and best practices.

• Provide internal clinical expertise for complex protocol questions and study decision‑making.

• Contribute to presentations, reporting, and cross‑department communication on research progress and outcomes.

Qualifications

Required

• MD or DO, board‑certified in Hematology/Oncology or related specialty.

• Minimum 5 years of experience in clinical research, including direct involvement in oncology clinical trials.

• Thorough knowledge of GCP, FDA regulations, and clinical trial conduct.

• Demonstrated ability to collaborate with multi‑disciplinary teams.

• Strong communication, leadership, and problem‑solving skills.

Preferred

• Prior experience serving as a Principal Investigator or Sub‑Investigator.

• Experience in Late Phase (Phase II/III/IV) oncology trial leadership.

• Familiarity with SOP development, operational workflows, and quality oversight frameworks.

Work Conditions

• Hybrid or on‑site depending on operational needs.

• Travel may be required for investigator meetings, study oversight visits, or operational leadership meetings (<25% typical for Late Phase roles).