Medical Director

ARTO; Miami (FL); On-site; USD 230,000 - 340,000; Full time

Job summary

ARTO is seeking a Medical Director / Principal Investigator to lead Phase I clinical studies in its established Miami, Florida unit. You will oversee participant safety, study conduct and regulatory compliance on-site with a multidisciplinary team in a 144-bed clinical pharmacology facility.

The ideal candidate has MD/DO, board certification, 5+ years of clinical research, and PI/Sub-Investigator/MEDDIR experience, with strong GCP knowledge and sponsor collaboration skills.

Qualifications

• MD or DO with an active medical license and ability to practice in Florida.
• Board certification in a medical specialty.
• Clinical research experience, with 5+ years preferred.
• Experience as a Principal Investigator, Sub-Investigator, Research Physician or Medical Director highly desirable.
• Phase I, clinical pharmacology, healthy-volunteer, FIH, PK/PD or early-phase research experience advantageous.
• Strong knowledge of GCP and clinical research regulations.
• BLS and ACLS certification.
• Strong communication skills and the ability to work effectively with sponsors and multidisciplinary clinical teams.

Responsibilities

• Serve as Principal Investigator or Sub-Investigator across clinical research protocols and assume FDA Form 1572 responsibilities.
• Provide medical oversight throughout study conduct, ensuring participant safety and compliance with ICH-GCP, FDA regulations and study protocols.
• Oversee participant selection and eligibility prior to dosing and review screening results against protocol requirements.
• Perform physical examinations, interpret ECGs and review laboratory and other clinical data.
• Assess and manage adverse medical events arising during studies.
• Provide physician oversight during study activities including drug administration and PK/PD assessments.
• Work closely with Clinical Operations and oversee physicians, Sub-Investigators, nurses and other clinical staff.
• Review study documentation, adverse-event assessments, interim summaries and clinical study reports.
• Contribute to development and review of clinical protocols and informed consent documents.
• Communicate directly with sponsors regarding study progress and participate in sponsor audits and FDA inspections.
• Support SOP development, CAPAs, staff training and continuous improvement across the clinical unit.

Skills

Clinical research experience

PI/Sub-Investigator experience

GCP knowledge

BLS/ACLS certification

Strong communication

Education

MD or DO with active medical license

Board certification in medical specialty

Job description

Medical Director / Principal Investigator – Phase I Clinical Research

Our partner, a leading global drug development organization supporting pharmaceutical and biotechnology companies, is seeking a Medical Director / Principal Investigator to join its established Phase I Clinical Research Unit in Miami, Florida.

This is an opportunity for a physician with clinical research experience to take a highly visible role within a dedicated 144-bed clinical pharmacology facility that has conducted almost 1,000 studies over the past 25 years and has access to a recruitment database of approximately 20,000 healthy volunteers.

The Medical Director / Principal Investigator will work hands-on across Phase I studies, taking responsibility for participant safety, medical oversight and study conduct while working closely with clinical operations teams and pharmaceutical and biotechnology sponsors.

Key Responsibilities

• Serve as Principal Investigator or Sub-Investigator across clinical research protocols and assume the associated FDA Form 1572 responsibilities.
• Provide medical oversight throughout study conduct, ensuring participant safety and compliance with ICH-GCP, FDA regulations and study protocols.
• Oversee participant selection and eligibility prior to dosing and review screening results against protocol requirements.
• Perform physical examinations, interpret ECGs and review laboratory and other clinical data.
• Assess and manage adverse medical events arising during studies.
• Provide physician oversight during study activities including drug administration and pharmacokinetic assessments.
• Work closely with Clinical Operations and oversee physicians, Sub-Investigators, nurses and other clinical staff.
• Review study documentation, adverse-event assessments, interim summaries and clinical study reports.
• Contribute to the development and review of clinical protocols and informed consent documents.
• Communicate directly with pharmaceutical and biotechnology sponsors regarding study progress and participate in sponsor audits and FDA inspections.
• Support SOP development, CAPAs, staff training and continuous improvement across the clinical unit.

Candidate Profile

Our partner is looking for a physician who can combine strong clinical judgement with an understanding of clinical research and participant safety.

Candidates should have:

• MD or DO with an active medical license and ability to practice in Florida
• Board certification in a medical specialty
• Clinical research experience, with 5+ years preferred
• Experience as a Principal Investigator, Sub-Investigator, Research Physician or Medical Director highly desirable
• Phase I, clinical pharmacology, healthy-volunteer, FIH, PK/PD or early-phase research experience advantageous
• Strong knowledge of GCP and clinical research regulations
• BLS and ACLS certification
• Strong communication skills and the ability to work effectively with sponsors and multidisciplinary clinical teams.

Why Consider This Opportunity?

This is a high-visibility physician position within a large, established Phase I research environment. The successful candidate will have the opportunity to take significant PI responsibility, work directly with leading pharmaceutical and biotechnology sponsors, mentor other clinical professionals and contribute to the continued development of the Miami research unit.

The position is on-site in Miami, Florida, and relocation can be considered for suitable candidates currently based elsewhere in the US.