Principal Scientist - Pharmacokinetics

Ascent invests a tremendous amount of time and money to ensure that we provide value to our client and industry relationships. Our CEO often tells clients that before they select a vendor they should leverage the knowledge of their peers at other companies in the industry.

• Seeking an outstanding candidate to join its DMPK/Clinical Pharmacology group in the role of Principal Scientist (Pharmacokinetics/Pharmacometrics).
• This individual will have extensive experience in pharmacokinetics, PK/PD modeling and simulation and population pharmacokinetics.

• Work closely with Translational Sciences, Clinical Development, Clinical Biometrics, Clinical Data Management and Clinical Operations staff and external vendors as a subject matter expert in pharmaceutical bioanalysis, pharmacokinetics, modeling and simulation and population PK analysis.
• Apply pharmacokinetic/pharmacodynamics (PK/PD) and modeling & simulation (M&S) approaches to characterize drug absorption and disposition and assess the dynamics of drug effect to inform dose selection and go/no-go decisions
• Work with preclinical and clinical CROs and company scientists to conduct and monitor clinical and preclinical studies, maintain study records and ensure study completion along program timelines
• Contributes to program PKPD strategy, study design, protocol preparation, study execution, data review/analysis, report preparation and regulatory document preparation.

• PhD or PharmD with 5+ years' experience as a Pharmacokineticist or Pharmacometrician in the pharmaceutical industry
• BS or MS with 10+ years' experience working as a Pharmacokineticist or Pharmacometrician in the pharmaceutical industry
• Excellent written and oral communication, interpersonal and problem solving skills
• Can manage multiple projects under tight timelines working independently and collaboratively on teams
• Extensive experience in Non Compartmental Analysis using WINNONLIN, PKPD modeling and simulation and population pharmacokinetics
• Knowledge of R, SAS or similar programming language and experience building NONMEM datasets
• Experience managing data transfer processes and timelines
• Experience writing clinical pharmacology/pharmacokinetic reports and regulatory submissions and performing quality control
• Working knowledge of regulatory requirements governing drug development activities
• Resourcefulness, pragmatism, and an independent work ethic