Quotient Sciences
Principal Investigator / Medical Director
Serve as Principal Investigator or Sub-Investigator overseeing medical services and licensed professional staff for phase I clinical pharmacology studies. Ensure compliance with GCP guidelines, subject safety, and accurate study data collection while supervising clinical staff and participating in study protocol development and regulatory communications.
Key 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
Required
- • Active Medical Doctor or Doctor of Osteopathy License, State of Florida
- • Must not be debarred, disqualified, or restricted by the FDA or State of Florida
- • Maintains BLS and ACLS certification
- • Maintains CITI Program certification
- • Board Certified in a medical specialty
Preferred
- • Minimum of five years of clinical research experience preferred
Quotient Sciences: Molecule to Cure. Fast.
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.
Why Join Us
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.
The Role
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.
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.
Why Join Us
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.
The Role
- 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
- 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
- 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
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.
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