Teva Pharmaceuticals USA, Inc.

Associate Director Bioanalytical PK/PD Biomarker (Biologics)

US-PA-West Chester
Requisition #
# Positions
Research & Development - Pharmaceutical


We are seeking a highly motivated Associate Director with a strong background in large molecule PK/PD-Biomarker method development for pre-clinical and clinical applications and proven leadership. You will lead and execute all PK/PD Biomarker activities undertaken within Biologics, Assays and Technology which plays a critical role in development of biological therapeutics from late stage of research, IND enabling GLP studies, clinical trials through BLA submission and post marketing support.


  • Lead a group of scientists and research associates for assay development and method validation to support nonclinical and clinical PK/PD-Biomarker;
  • Interact with the functional teams within the department as well as outside groups to represent GBT PK/PD-Biomarker functional area;
  • Provide technical expertise, strategies and make decisions for PK/PD-Biomarker needs;
  • Review clinical study protocols, reports and regulatory submission documents
  • Write regulatory submission document including method validation reports, bioanalytical reports and correspondence documents
  • Oversee outsourced works to ensure the delivery of the highest quality data within timeline and budget


  • Ph.D. degree in relevant scientific field with a minimum of 9 years of experience in the Pharmaceutical/ Biotech/ Bioanalytical Laboratory or industry setting
  • The candidate must have strong leadership, management experience (2 -3 years minimum leading a group of Scientists)
  • In-depth understanding and hands-on expertise of PKPD-Biomarker ligand-binding assay platforms applicable in clinical development.
  • Knowledge of Regulatory Guidance,  work with Regulatory Agencies,  experience in preparing regulatory documents and/or interacting with regulatory agencies is required
  • Strong GLP/ GCP experience
  • Excellent oral and written communication skills.



Very good understanding of LC-MS applicable to Biomarker and or large molecule.  Knowledge of Regulatory Guidance





Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
Share on your newsfeed

Connect With Us!

Not ready to apply? Connect with us for general consideration.