We are currently seeking qualified candidates for a Senior Clinical Pharmacokineticist role with a global contract development and manufacturing organisation. This is a permanent position that will be based out of Nottingham, United Kingdom.
The Senior Clinical Pharmacokineticist 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 Client’s PK services. Our Client’s 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.
- 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
EDUCATION, SKILLS & 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