Senior Pharmacokineticist

Job description

Role & responsibilities • Job Description: • Act as a scientific and technical resource person within Syneos Health for the pharmacokinetics and pharmacodynamics fields and perform complex pharmacokinetic and/or pharmacodynamic analyses. • Calculate pharmacokinetic parameters and perform statistical analyses on bioanalytical and clinical (or nonclinical) data using tested or validated software • Write the pharmacokinetic and statistical sections of clinical (early and late phases) or nonclinical (toxicokinetic studies) reports including interpretation of the results • Participate in intra and/or extra company scientific consultancy • Answer to deficiency letters from regulatory agencies on the conduct of the pharmacokinetic and statistical analyses performed during clinical studies • Participate to the quotation process for the functional area activities using internal database, literature data and pricing grid • Review study protocol in accordance with regulatory requirements using internal and/or literature data, and design information appearing in inhouse database. • Write/review standard operating procedures related to his/her work • Use quantitative approaches to integrate knowledge of PK, PD, efficacy, safety, patient demographics, and pathophysiological factors to facilitate product development and decision making under the supervision of pharmacometricians • Participate in the development of structured and standardized data modeling practices and related SOPs • Act as a consultant in clinical pharmacology study design development (e.g., optimal sampling, protocol review, etc.) • Perform comprehensive quality control/peer review procedures • Act as a scientific and technical resource person within Syneos Health for the pharmacokinetics and pharmacodynamics fields and perform complex pharmacokinetic and/or pharmacodynamic analyses. • Calculate pharmacokinetic parameters and perform statistical analyses on bioanalytical and clinical (or nonclinical) data using tested or validated software • Write the pharmacokinetic and statistical sections of clinical (early and late phases) or nonclinical (toxicokinetic studies) reports including interpretation of the results • Participate in intra and/or extra company scientific consultancy • Answer to deficiency letters from regulatory agencies on the conduct of the pharmacokinetic and statistical analyses performed during clinical studies • Participate to the quotation process for the functional area activities using internal database, literature data and pricing grid • Review study protocol in accordance with regulatory requirements using internal and/or literature data, and design information appearing in inhouse database. • Write/review standard operating procedures related to his/her work • Use quantitative approaches to integrate knowledge of PK, PD, efficacy, safety, patient demographics, and pathophysiological factors to facilitate product development and decision making under the supervision of pharmacometricians • Participate in the development of structured and standardized data modeling practices and related SOPs • Act as a consultant in clinical pharmacology study design development (e.g., optimal sampling, protocol review, etc.) • Perform comprehensive quality control/peer review procedures Preferred candidate profile Perks and benefits