Senior Scientist Pharmacokinetics
Synteract
Bloemfontein, South Africa
5d ago

Who We Are

Synteract®, a Syneos Health® company, is a leading full service Contract Research Organization (CRO) with a successful three-decade track record of supporting emerging biotech and pharmaceutical companies.

With our mission of Bringing clinical trials to lifeTM , we provide customized Phase I through IV services globally, offering expertise across multiple therapeutic areas, including notable depth in oncology, dermatology, general medicine, infectious disease and vaccine, neuroscience, pediatrics, and rare and orphan diseases.

Position Overview Provide pharmacology, pharmacokinetic consulting to clients with a specialization on pediatric patient populations.

Design, analyze and report pre-clinical and clinical pharmacokinetic, PK / PD modeling and trial simulation studies. Specific tasks would include

  • Work with client’s data management group to prepare datasets for import and analysis in WinNonLin.
  • Conduct non-compartmental (NCA) and compartmental PK analysis in Phoenix WinNonLin-PKSo.
  • Responsible for locking and unlocking studies / scenarios in the PKSo database following management authorization.
  • Write stand-alone PK reports and PK study report sections for CSR’s
  • Responsible for ensuring study data and study reports are retained according to the corporate records retention policy.
  • Ensuring corporate quality policies and SOPs are followed during the analysis and reporting of PK studies
  • Provide pharmacology, pharmacokinetic and drug development consulting services to clients with a specialization in pediatric drug development.
  • Under management approval act as client lead to handle complex modeling projects.
  • Conduct PK / PD modeling and population PK and / or physiologically based PK analyses using WinNonlin, NONMEM and PK-Sim.
  • Lead or participate in the PK / PD team responsible for designing and validating analysis data sets, programs, and PK output products (tables, listings, figures).
  • Act as the project manager to include functioning as the principal liaison with key clients, vendors, and internal team members.
  • Provide pharmacology, pharmacokinetic and drug development consulting services to clients with a specialization in pediatric drug development.
  • Assist clients in the design and development of pre-clinical and clinical protocols with respect to toxicokinetic and pharmacokinetic analyses.
  • Create trust and confidence among clients, vendors and team members while delivering on-time, and on-budget programs that leverage the various resources, expertise and cross function knowledge available.
  • Qualifications

  • Ph.D. or Master’s Degree in Pharmacokinetics or Pharmaceutical Sciences, plus knowledge of how to support pediatric Pharmacokinetic / Pharmacodynamics modeling and simulations, specifically population PK and / or physiological based PK.
  • 3+ years related experience or equivalent combination of education and experience (Including post-doctoral experience).
  • Advanced knowledge dosing methodologies especially in First in human (FIH) and pediatrics including allometric scaling approaches.
  • Advanced knowledge of GCPs, ICH guidelines, FDA and other applicable country regulations.
  • Working experience with Phoenix WinNonlin (required).
  • Knowledge of Pharmacometrics tools (NONMEM, R, PK-SIM, Simcyp, etc.) is highly preferable.
  • Intermediate proficiency in Microsoft Word, MS Project, Excel, and PowerPoint, Outlook.
  • Effective verbal and writing skills; English + local language, if relevant.
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