Principal Investigator / Medical Director

Quotient Sciences is a drug development and manufacturing accelerator providing integrated programs and tailored services across the entire development pathway. Cutting through silos across a range of drug development capabilities, we help biotech and pharma customers save precious time and money in getting drugs to patients.

We employ more than 1,100 talented individuals globally, located at state-of-the-art development, manufacturing and clinical facilities in the UK and USA.

Science, Agility and Culture are the core components that define Quotient Sciences, enabling us to do what we do in the way that we do it. People join Quotient Sciences because we are a respected member of the drug development community that's focused on innovation and are driven by an unswerving belief that ideas need to become solutions, and molecules need to become cures, fast. Because humanity needs solutions, 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.

Summary of job purpose

• 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

Qualifications and experience required for competent performance

• 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

Main tasks and responsibilities

• 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

Additional Tasks/responsibilities

• 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

Job Demands

• The job may involve the following:
• Very high concentration of work
• Strict and tight deadlines
• Having to juggle a range of tasks/issues simultaneously
• Working in a hazardous environment with high requirement to follow safety procedures
• Working outside normal working hours
• Needing to respond to client demands

Application Requirements

When applying for a position with Quotient Sciences to be able to work in our organization you must be aged 18 years or over and not have been debarred by the FDA. If you indicate you are under the age of 18 or have been debarred then your application will be automatically declined.

Our Commitment to Diversity, Equity and Inclusion

Quotient Sciences are advocates for positive change and conscious inclusion. We strive to create a diverse Quotient workforce and develop a workplace culture that provides a sense of acceptance for every person within our organization. As a global employer, we recognize the value in having an organization that is a true reflection and representation of our society today.

Specifically we will not discriminate on the basis of race, color, creed, religion, gender, gender identity, pregnancy, marital status, partnership status, domestic violence victim status, sexual orientation, age, national origin, alienage or citizenship status, veteran or military status, disability, medical condition, genetic information, caregiver status, unemployment status or any other characteristic prohibited by federal, state and/or local laws.

This applies to all aspects of employment, including hiring, promotion, demotion, compensation, training, working conditions, transfer, job assignments, benefits, layoff, and termination.