Medical Director

Principal Investigator / Medical Director

Miami, Florida

Our client, a leading global drug development and manufacturing partner, is seeking an experienced Principal Investigator / Medical Director to join its state-of-the-art Clinical Pharmacology Unit in Miami, Florida.

With more than three decades of experience supporting pharmaceutical and biotechnology companies, the organization provides integrated drug development solutions spanning formulation development, clinical pharmacology, clinical trials, and commercial manufacturing. Through a unique model that combines drug product manufacturing with clinical testing, the company helps accelerate development timelines, reduce costs, and improve outcomes for sponsors bringing innovative therapies to patients.

About the Opportunity

This position is based at the company's Miami clinical pharmacology facility, a highly regarded Phase I research centre that has successfully conducted close to 1,000 studies over the last 25 years. The site features 144 inpatient beds and access to an extensive healthy volunteer database, enabling rapid study start-up and efficient study execution.

The successful candidate will play a critical leadership role in ensuring the safe and compliant conduct of clinical research studies while serving as Principal Investigator or Sub-Investigator across a range of early-phase clinical trials.

Key Responsibilities

• Serve as Principal Investigator or Sub-Investigator on clinical research protocols conducted at the Miami facility.
• Ensure all studies are conducted in compliance with ICH-GCP guidelines, FDA regulations, protocol requirements, and applicable regulatory standards.
• Maintain oversight of participant safety throughout all phases of study conduct.
• Supervise study-related medical activities, including physician staff and licensed healthcare professionals.
• Oversee subject eligibility assessments and final participant selection prior to dosing.
• Provide medical oversight during dosing and pharmacokinetic sampling periods as required.
• Evaluate and manage adverse events and other participant safety concerns.
• Conduct physical examinations, review ECGs, and assess laboratory results.
• Collaborate with Clinical Operations and site leadership to ensure efficient study execution.
• Participate in on-call coverage and emergency response procedures.
• Review and approve study documentation, adverse event assessments, interim study summaries, and final clinical study reports.
• Support protocol development, informed consent review, and other study-related documentation.
• Participate in sponsor interactions and provide medical input on study progress.
• Support regulatory inspections and sponsor audits as required.

Additional Responsibilities

• Contribute to the review and revision of Standard Operating Procedures (SOPs).
• Assist with quality initiatives, including investigations, Notes to File, CAPAs, and process improvements.
• Attend internal and sponsor-facing meetings.
• Support the training and development of medical and clinical staff.
• Deliver educational sessions and participate in emergency preparedness training activities.

Candidate Profile

• MD or DO with an active and unrestricted medical license
• Board certification in a recognized medical specialty.
• Minimum of five years' clinical research experience preferred.
• Strong knowledge of FDA regulations, ICH-GCP guidelines, and clinical trial conduct.
• Current BLS and ACLS certification.
• Current CITI certification.
• Must not be debarred, disqualified, or otherwise restricted by the FDA or the State of Florida.

Working Environment

This is a highly visible leadership position within a fast-paced clinical research environment. The role requires:

• The ability to manage multiple priorities simultaneously.
• Strong attention to detail and decision-making under pressure.
• Flexibility to work outside standard business hours when required.
• Responsiveness to sponsor and study demands.
• Strict adherence to safety, compliance, and quality standards.

Why Apply?

This is an opportunity to join a respected organization at the forefront of clinical drug development and play a direct role in advancing innovative medicines through early-stage research. The successful candidate will work alongside a highly experienced clinical research team and contribute to studies that help bring new therapies to patients faster.