Medical Director - Late Phase Research

Florida Cancer Specialists

28d•Hybrid

About The Position

At Florida Cancer Specialists & Research Institute, we believe our people are our strength and we invest in them. In addition to having a positive impact on the people and communities we serve, associates benefit from significant professional opportunities, career advancement, training and competitive wages. Offering competitive salaries and comprehensive benefits packages to include tuition reimbursement, 401-K match, pet and legal insurance. A LITTLE BIT ABOUT FCS Since 1984, Florida Cancer Specialists & Research Institute & Research Institute (FCS) has built a national reputation for excellence. With over 250 physicians, 220 nurse practitioners and physician assistants and nearly 100 locations in our network. Utilizing innovative clinical research, cutting-edge technologies, and advanced treatments, we are committed to providing world-class cancer care. We are recognized by the American Society of Clinical Oncology (ASCO) with a national Clinical Trials Participation Award, FCS offers patients access to more clinical trials than any private oncology practice in Florida. Our patients have access to ground-breaking therapies, in a community setting, and may participate in national clinical research studies of drugs and treatment protocols. In the past five years, the majority of new cancer drugs approved for use in the U.S. were studied in clinical trials with FCS participation prior to approval. Through our partnership with Sarah Cannon, we are one of the largest clinical research organizations in the United States. Often, FCS leads the nation in initiating research studies and offering ground-breaking new therapies to patients. Come join us today! 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.

Requirements

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.

Nice To Haves

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.

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.