(Sr) Pharmacokineticist - UK

Pharmacokineticist / Senior Pharmacokineticist -Home-based (UK)

We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health.You will be joining a trulycollaborative and winning culture as we strive to bend the time and cost curve of deliveringlife-saving therapies to patients.

The clinical pharmacology department is comprised of approximately 40 pharmacokineticists and SAS programmers who routinely evaluate pharmacokinetic (PK) and pharmacokinetic/pharmacodynamic (PK/PD) relationships in support of our clients’ new and generic drug development efforts.

Within the clinical pharmacology department, the pharmacokineticist / senior pharmacokineticist is responsible for the design, analysis, interpretation and reporting of PK and/or pharmacodynamic (PD) data across all stages of clinical development (Phases I-IV). The pharmacokineticist / senior pharmacokineticist provides PK consultation as well as individual study oversight responsibilities, managing individual projects requiring noncompartmental and/or population PK/PD modelling analyses.

This position requires pharmacokinetic experience in a clinical research, contract research organisation (CRO) or pharmaceutical environment. The ideal candidate must be flexible and adaptive, able to work on multiple projects simultaneously, and able to identify, prioritise and shift resources regularly to manage competing timelines and priorities. All studies must be conducted in accordance with individual study/client requirements and regulatory guidelines (eg, FDA, EMA, GCP), therefore attention to detail and the ability to follow set procedures is essential.

Both pharmacokineticist and senior pharmacokineticist roles are available, depending on experience.

Pharmacokineticist / Senior Pharmacokineticist -Home-based (UK)

We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health.You will be joining a trulycollaborative and winning culture as we strive to bend the time and cost curve of deliveringlife-saving therapies to patients.

The clinical pharmacology department is comprised of approximately 40 pharmacokineticists and SAS programmers who routinely evaluate pharmacokinetic (PK) and pharmacokinetic/pharmacodynamic (PK/PD) relationships in support of our clients’ new and generic drug development efforts.

Within the clinical pharmacology department, the pharmacokineticist / senior pharmacokineticist is responsible for the design, analysis, interpretation and reporting of PK and/or pharmacodynamic (PD) data across all stages of clinical development (Phases I-IV). The pharmacokineticist / senior pharmacokineticist provides PK consultation as well as individual study oversight responsibilities, managing individual projects requiring noncompartmental and/or population PK/PD modelling analyses.

This position requires pharmacokinetic experience in a clinical research, contract research organisation (CRO) or pharmaceutical environment. The ideal candidate must be flexible and adaptive, able to work on multiple projects simultaneously, and able to identify, prioritise and shift resources regularly to manage competing timelines and priorities. All studies must be conducted in accordance with individual study/client requirements and regulatory guidelines (eg, FDA, EMA, GCP), therefore attention to detail and the ability to follow set procedures is essential.

Both pharmacokineticist and senior pharmacokineticist roles are available, depending on experience.

Education and Experience:

Required: Bachelor of Science (BSc) or Masters (MSc) degree in pharmacology or a related field

Preferable: Ph.D. or PharmD with an emphasis on clinical pharmacokinetics

2 years experience in a pharmaceutical, CRO, or other relevant setting

Experience managing/overseeing pharmacokinetic programs with a proven record of accomplishment

Knowledge, Skills and Abilities:

Understanding and awareness of FDA, EMA, GCP, and other regulatory requirements pertaining to pharmacokinetic/pharmacodynamic/ bioavailability/bioequivalence analyses

Strong theoretical background in pharmacokinetics with PK/PD experience and the ability to apply PK theory and concepts using noncompartmental and/or population modelling approaches

Experience using Phoenix WinNonlin, Phoenix NLME, NONMEM, SimCyp, GastroPlus, SAS, or other pharmacokinetic software

Knowledge of CDISC principles (particularly SDTM and ADaM)

Excellent organizational, communication, and problem-solving skills are essential If you have the required skills and experience please apply now! Alternatively, you can contact Adam Davis, Senior Recruiter, on adam.davis@ppdi.com for more information.

#LI-AD1

Education and Experience:

Required: Bachelor of Science (BSc) or Masters (MSc) degree in pharmacology or a related field

Preferable: Ph.D. or PharmD with an emphasis on clinical pharmacokinetics

2 years experience in a pharmaceutical, CRO, or other relevant setting

Experience managing/overseeing pharmacokinetic programs with a proven record of accomplishment

Knowledge, Skills and Abilities:

Understanding and awareness of FDA, EMA, GCP, and other regulatory requirements pertaining to pharmacokinetic/pharmacodynamic/ bioavailability/bioequivalence analyses

Strong theoretical background in pharmacokinetics with PK/PD experience and the ability to apply PK theory and concepts using noncompartmental and/or population modelling approaches

Experience using Phoenix WinNonlin, Phoenix NLME, NONMEM, SimCyp, GastroPlus, SAS, or other pharmacokinetic software

Knowledge of CDISC principles (particularly SDTM and ADaM)

Excellent organizational, communication, and problem-solving skills are essential If you have the required skills and experience please apply now! Alternatively, you can contact Adam Davis, Senior Recruiter, on adam.davis@ppdi.com for more information.

#LI-AD1