Principal Investigator / Medical Director

Quotient Sciences • Miami, FL

8d • Onsite

About The Position

Quotient Sciences is a leading drug development and manufacturing accelerator, helping biotech and pharma companies bring new medicines to patients faster. With over 35 years of experience and a track record of success, we provide Drug Product (CDMO) and Clinical (CRO) services across the entire development pathway, including formulation development, clinical pharmacology, clinical trials, and commercial product manufacturing. Our proprietary and disruptive platform – “Translational Pharmaceutics®” – integrates Drug Product Manufacturing and Clinical Testing to eliminate silos in the drug development process. This in turn reduces costs, improves outcomes, and significantly accelerates drug development times. Because every day counts when bringing new medicines to patients. Our 1,000+ experts across the US, UK, and beyond are united by science, agility, and a culture that turns ideas into impact—fast. An excellent opportunity for a Principal Investigator/ Medical Director to join Quotient Sciences – Miami, a dedicated, state-of-the-art, clinical pharmacology facility. The Miami site specializes in phase I clinical pharmacology studies with a proven track record of almost a thousand studies over the past 25 years. With 144 beds and a large recruitment database of 20,000 healthy volunteers, we’re known for being able to rapidly start up new studies in record time and complete studies quickly with full cohorts of subjects. Join us as a Principal Investigator/ Medical Director and help us to develop new medicines and get them to patients faster.

Requirements

• Active Medical Doctor or Doctor of Osteopathy License, State of Florida
• Minimum of five years of clinical research experience preferred
• Board Certified in a medical specialty
• Must not be debarred, disqualified, or restricted by the FDA or State of Florida
• Maintains BLS and ACLS certification
• Maintains CITI Program certification
• Aged 18 years or over
• Not have been debarred by the FDA

Responsibilities

• Serve as Principal Investigator or Sub-Investigator on protocols undertaken by Quotient Sciences-Miami and is responsible for overseeing medical services and licensed professional staff
• Comply & adhere to GCP guidelines and regulations
• Ensure study data is collected in accordance with Good Clinical Practice (GCP) standards
• Ensure subject safety at all times
• Serve as Principal Investigator or Sub-Investigator on FDA form 1572 for protocols conducted.
• Satisfactorily perform and comply with all responsibilities of a clinical investigator including, but not limited to those specified in the ICH Guidelines for Good Clinical Practice, FDA form1572, FDA Rules and Regulations and other Investigator’s obligations specified in pharmaceutical company protocols and contracts
• Supervise morning drug administration at the overnight facility on those days when pharmacokinetic profiles are obtained or Physician presence is required for safety purposes
• Directly supervise the final selection of study participants from the time of clinic admission until actual drug exposure takes place
• Attends to adverse medical events
• Perform physical exams, read ECG’s and review laboratory data for protocols conducted
• Review screening results as necessary to assemble qualified research participant cohorts according to protocol stipulations
• Work in concert with site and Clinical Operations to provide supervision and organization of physician, sub-Investigators, nurses and clinical staff
• Maintain familiarity with crash cart and emergency resuscitation procedures
• Participate in on-call rotation
• Review completed data entry and sign-off of completed study documentation in a timely manner including a careful review and sign-off of adverse assessments, study interim summaries, as well as clinical study reports
• Participate in writing and editing of protocols and informed consents for clinical studies
• Be available and participate in communications with sponsor in regard to study progress
• Be available for FDA inspections and Pharmaceutical Sponsor Audits
• Review SOPs and assist with SOP revisions when applicable
• Assist in drafting Notes to File
• Identify quality issues and help draft and implement CAPAs
• Attend department and sponsor meetings
• Assist in training new staff (other MDs and/or ARNPs/PAs) as necessary
• Give educational lectures and participates in Mock Code training as necessary

What This Job Offers

• Job Type: Full-time
• Career Level: Senior