US ~ Miami
Senior Medical Director-Principal Investigator
Our growing and successful business comprises of over 700 talented individuals globally, in an environment where everybody counts and is instrumental to our success. With state-of-the-art manufacturing and clinical facilities in the UK and USA, we deliver a full range of drug development solutions around the globe saving our clients both time and money.
People join Quotient Sciences because we are a respected member of the drug development world, specializing in delivering innovative solutions that integrate formulation development, real-time GMP manufacturing, and clinical testing. We pride ourselves on the quality of our services and our engaged culture. We are passionate about helping our customers get new medicines to market.
Summary of job purpose
The Senior Medical Director / Principal Investigator is responsible for overseeing all medical services and the overall clinical trial conduct. Overall accountability for medical oversight/supervision of all clinical trials in the Miami unit. Accountable for supporting/triaging new opportunities and supporting the medical team as needed during conduct of trials.
Qualifications & experience required for competent performance
Board Certified in a medical sub specialty (cardiology, endocrinology, nephrology, gastroenterology, critical care, pulmonary, infectious disease, rheumatology, clinical pharmacology.)
Five years clinical research experience including role as Principal Investigator with particular experience in first-in-human trials that have a broad experience in the design/conduct of a full range of Phase I studies.
State of Florida medical license.
American medical school preferred not required.
Formal training in clinical pharmacology or board certification in pharmacology with a breadth of knowledge on PD measures/procedures preferred not required.
Main tasks and responsibilities
Serve as Principal Investigator or delegate role to other qualified physician staff.
Provide medical supervision of professional staff to include physicians, pharmacists, physician assistants and nurse practitioners.
Evaluate protocol proposals from a medical, safety and feasibility standpoint.
Edit and provide medical input to synopses, protocols and new proposals.
Determine facility needs from a medical and technical perspective.
Provide Medical Input to business development to ensure feasibility from a medical proficiency and data integrity perspective.
Provide medical input into study designs to support the development of clinical studies to meet Sponsor needs.
Provide expert advice on logistics of clinical study execution to ensure data integrity and volunteer safety.
Ensure all medical and clinical activities are conducted in line with the necessary health & safety, legal, financial, quality and regulatory compliance requirements, in accordance with company and external guidelines.
Ensure adequate recruitment, training and development of the medical team to maintain a highly motivated, skilled and efficient group to meet the needs of the Miami business.
Provide supervision, mentoring and direction to the medical team, ensuring clear annual objectives for performance to be measured against, and hold regular meetings to review progress.
Provide mentoring and direction to the clinical team to ensure volunteer safety at all times.
Drive continuous improvements within the Miami operations to deliver operational efficiencies and enhanced compliance standards.
Research, development and implementation of innovative operational capabilities to drive business growth.
Build and maintain strong relationships to ensure first class service provision from the medical group to other members of the Quotient team and Sponsors.
Participate in client or regulatory audits as required.
Support studies as a Principal Investigator or Sub-Investigator in the event of a temporary vacancy or absence.
Overall accountability for the clinical lab to ensure compliance with local regulations and support of clinical studies on time, in full.
Overall accountability for pharmacy operations to ensure compliance with local regulations and support of clinical studies on time, in full.
Work with Finance to agree annual medical, pharmacy and clinical laboratory budget, including labour resource planning.
Monitor monthly performance against budget with aim of achieving/exceeding annual target(s).
Report on variances and provide insight into future deviations to budget.
Propose annual remuneration increases for employees within your functions.
Provide with justification capital expenditure requirements using the Company CAPEX Request Form.
The job may involve the following:
Having to manage a range of tasks/issues simultaneously
Strict and tight deadlines
Very high concentration of work
Working outside normal working hours
Needing to respond to client demands
Working in a hazardous environment with high requirement to follow safety procedures
This Job Description is designed to clarify responsibilities, assist in benchmarking performance, and provide information for job applicants. It is not intended to restrict a job holder’s development or level of performance.
Significant changes to job content will be reviewed at Performance Review discussions which may result in amendments being made.