Posted Thursday 5 December 2024 at 06:00
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.
The Senior Medical Director / Principal Investigator is responsible for overseeing all medical services and the overall clinical trial conduct and 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.
Main tasks and responsibilities Serve as Principal Investigator or delegate role to other qualified physician staffProvide medical supervision of professional staff to include physicians, pharmacists, physician assistants, and nurse practitionersEvaluate protocol proposals from a medical, safety, and feasibility standpointEdit and provide medical input to synopses, protocols, and new proposalsDetermine facility needs from a medical and technical perspectiveProvide medical input to business development to ensure feasibility from a medical proficiency and data integrity perspectiveProvide medical input into study designs to support the development of clinical studies to meet Sponsor needsProvide expert advice on logistics of clinical study execution to ensure data integrity and volunteer safetyEnsure 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 guidelinesEnsure 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 businessProvide supervision, mentoring, and direction to the medical team, ensuring clear annual objectives for performance to be measured against, and hold regular meetings to review progressProvide mentoring and direction to the clinical team to ensure volunteer safety at all timesDrive continuous improvements within the Miami operations to deliver operational efficiencies and enhanced compliance standardsResearch, develop, and implement innovative operational capabilities to drive business growthBuild and maintain strong relationships to ensure first-class service provision from the medical group to other members of the Quotient team and SponsorsParticipate in client or regulatory audits as requiredSupport studies as a Principal Investigator or Sub-Investigator in the event of a temporary vacancy or absenceQualifications and experience Board Certified in a medical sub-specialty (cardiology, endocrinology, nephrology, gastroenterology, critical care, pulmonary, infectious disease, rheumatology, clinical pharmacology)University TrainedFive 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 studiesState of Florida medical licenseAmerican medical school preferred but not requiredFormal training in clinical pharmacology or board certification in pharmacology with a breadth of knowledge on PO measures/procedures preferred but not requiredOverall accountability for the clinical lab to ensure compliance with local regulations and support of clinical studies on time, in fullOverall accountability for pharmacy operations to ensure compliance with local regulations and support of clinical studies on time, in fullBudgetary responsibility. Work with Finance to agree on annual medical, pharmacy, and clinical laboratory budget, including labor resource planningMonitor monthly performance against budget with aim of achieving/exceeding annual target(s)Report on variances and provide insight into future deviations to budgetPropose annual remuneration increases for employees within your functionsProvide with justification capital expenditure requirements using the Company CAPEX Request FormApplication Requirements When applying for a position with Quotient Sciences, to be able to work in our organisation 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 organisation. As a global employer, we recognise the value in having an organisation that is a true reflection and representation of our society today.
Specifically, we will not discriminate on the basis of race, colour, 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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