- 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 perks
📌 Senior Pharmacokineticist (Hyderabad)
🏢 Syneos Health
📍 Hyderabad
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