UK ~ Nottingham
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, specialising 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.
Due to our continued growth and success we have an excellent opportunity for a talented Clinical Pharmacokineticist to join our Pharmacokinetics Department, within Data Sciences. You will be involved in the challenging environment of early phase clinical research and play a key role in the expansion and continuous development of our PK services.
Data Sciences at Quotient Sciences comprises over 60 staff and provides an expert service in the data management, analysis and reporting of early Phase clinical studies (both healthy volunteer and patient).
As a member of our Pharmacokinetics department, you will be trained and eventually responsible for:
- Pharmacokinetic input to and review of Clinical Protocols and Reporting and Analysis Plans
- Non-compartmental pharmacokinetic analysis and data interpretation
- Providing interpretive pharmacokinetic expertise to inform dose decision making strategies
- Utilising modelling functionality to support emerging questions arising from clinical data e.g. Compartmental Modelling, Non-Parametric Superposition, basic PK/PD modelling
- Providing Pharmacokinetic, Pharmacodynamic and Clinical Pharmacological interpretive reports for inclusion in Clinical Study Reports
At Quotient, our early Phase studies present particular PK challenges due to their complexity (often with multiple study parts), interim modelling, interpretation, protocol changes and the urgent requirement from sponsors for their key results; you will be expected to be flexible and creative in your PK skills.
The successful candidate must have the following essential experience:
- Scientific degree in a field related to Pharmacokinetics (e.g. Pharmacology, Biochemistry, Pharmaceutical Chemistry etc.)
- Minimum of least 1-3 years of Pharmacokinetics experience
- Experience of WinNonlin/Phoenix®
- Knowledge of ICH GCP and clinical trials
The following additional experience would be advantageous in this role:
- Experience in a range of clinical studies e.g. of First in Human , DDI, Drug Product Optimisation, Bioequivalence and ADME
- Familiarity with a combination of the following - regulatory bioanalysis, drug metabolism, formulation development, human dose prediction/justifications, PBPK, and pre-clinical safety data utility in the clinical setting
- Familiarity with related software/processes e.g. SAS®, CDISC terminology, statistical methodologies etc.
- Experience of working with Data Management, Statistical Programming, Statistics and Medical Writing departments
In addition you should have good organisational and presentation skills and be able to work to deadlines whilst maintaining quality standards. Attention to detail and the ability to multitask are essential. Effective oral and written communication skills are also required as you will be involved in pharmacokinetic point of contact with clients, regulators and clinical staff.
Applicants must have the right to work in the UK upon being offered employment.
This role will be based in our Nottingham site.
In return you will receive a competitive salary, a generous benefits package, excellent training and development, as well as an exciting career within a fast paced and dynamic business.