Sr Pharmacokineticist

Location
Home, AUS
Salary
Competitive
Posted
24 Mar 2021
Closes
14 Apr 2021
Ref
21001281
Discipline
R & D , Pharmacology
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
Why Syneos Health? Join a game-changing company that is reinventing the way therapies are developed and commercialized. Created through the merger of two industry leading companies, INC Research and inVentiv Health, we bring together more than 22,000 clinical and commercial minds to create a better, smarter, faster way to get biopharmaceutical therapies into the hands of patients who need them most. Evolve in a global company that is always looking for ways to work smarter and more efficiently as the only fully integrated Biopharmaceutical Accelerator. You'll be supported with comprehensive resources based on today's emerging technologies, data, science and knowledge - instead of practices from the past. Teaming with some of the most talented professionals in the industry, you'll gain exposure and work in a dynamic environment to over-deliver and outperform. A career with Syneos Health means your everyday work improves patients' lives around the world.

Position: Senior Pharmacokineticist

Tasks and Responsibilities

The Senior Pharmacokineticist acts as a scientific and technical resource person within Syneos Health for the pharmacokinetics and pharmacodynamics fields, and performs complex pharmacokinetic and/or pharmacodynamic analyses.
  • Calculate pharmacokinetic parameters and perform statistical analyses on bioanalytical and clinical (or non-clinical) data using tested or validated software
  • Write the pharmacokinetic and statistical sections of clinical (Phase I or bioequivalence studies) or non-clinical (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 the course of 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 in-house 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
  • Write data analysis plans in collaboration with the statisticians and pharmacometricians


Requirements
  • Master's degree in Science, 4 years of experience or Ph. D, 2 years of experience in a similar position in pharma industries or CRO. An equivalent combination of education, training and experience can be considered
  • Appropriate communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade.
  • In-depth understanding and knowledge of the pharmaceutical industry and contract research organizations in general, and the clinical community specifically
  • Experience with software Phoenix WinNonlin
  • English level: Required English proficiency includes being able to communicate verbally on subjects that are frequently scientific and specialized.
  • Other (optional): Candidate who does not possess the required training and/or experience may be considered under different criteria.

Disclaimer:

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.