Senior Clinical Pharmacokineticist

Quotient Sciences ,
Nottingham, Nottinghamshire
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Overview

Company Overview Our growing and successful business comprises of over 850 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. The Role Due to our continued growth and success we have an excellent opportunity for a talented Senior 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 over70 staff and provides an expert service in the data management, analysis and reporting of early Phase clinical studies (both healthy volunteer and patient). 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. You will also take on a Lead study role for PK tasks and become involved in study/programme design discussions including sponsor contact. The Senior Clinical Pharmacokineticist will also be responsible for: Acting as the Lead Pharmacokineticist providing PK project oversight Provision of scientific expertise to aid in the design, conduct, and reporting of clinical studies Pharmacokinetic input to and review of Clinical Protocols and Reporting and Analysis Plans Oversight and or provision of non-compartmental pharmacokinetic analysis Providing interpretive pharmacokinetic expertise to inform dose decision making strategies, including acting as a key member of safety review committee’s 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 Mentoring junior staff in a scientific capacity Candidate Profile The successful candidate must have the following experience: Scientific degree in a field related to Pharmacokinetics (e.g. Pharmacology, Biochemistry, Pharmaceutical Chemistry etc.) Minimum of least 3-5 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: Previous project lead experience e.g. scheduling and resource management Line management, or experience of mentoring junior staff 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 Utilisation of modelling and simulation techniques supporting clinical strategy decision making 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 a primary 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 can be based in our Nottingham or Edinburgh offices or potentially home based. Company benefits: In return you will receive a compet This job was originally posted as www.totaljobs.com/job/89847458

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