GSK

Director, Quantitative Clinical Pharmacologist

GSK

full-time

Posted on:

Location Type: Office

Location: Upper Providence • Massachusetts • Pennsylvania • United States

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Salary

💰 $183,150 - $305,250 per year

Job Level

Lead

About the role

  • Lead key activities to progress your career in quantitative clinical pharmacology
  • Contribute to the design of clinical development program and support life cycle management of an asset
  • Provide application of Clinical Pharmacokinetic (PK), Pharmacodynamic (PD), and Modeling & Simulation (MS) principles towards efficient drug development
  • Predict human dose range, characterize exposure-response relationship and justify dose recommendations
  • Develop mathematical models to understand disease and drug pharmacodynamics
  • Write sections of drug development documents and clinical trial protocols

Requirements

  • Advanced Degree in Life science such as PhD, PharmD or MD
  • 5 years + experience in clinical pharmacokinetics, modelling & simulation and model-informed drug development including designing, analysing and reporting clinical studies
  • Pharmacometric experience for Oncology assets including ADCs
  • 2 years + experience of pharmacokinetic and pharmacodynamic principles and commonly applied models
  • 1 year + experience working with common tools for quantitative clinical pharmacology such as NONMEM, R, WINNONLIN, SIMCYP, SAS and MATLAB
  • 1 year + experience with regulatory submission documents
  • 1 year + experience applying appropriate FDA and ICH guidelines
Benefits
  • health care and other insurance benefits (for employee and family)
  • retirement benefits
  • paid holidays
  • vacation
  • paid caregiver/parental and medical leave
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
clinical pharmacokineticspharmacodynamicsmodeling & simulationmathematical modelingdrug developmentdose recommendationsexposure-response relationshipclinical study designdata analysisreporting
Certifications
PhDPharmDMD