Teva Pharmaceuticals USA, Inc.

Associate Director Bioanalytical PK/PD Biomarker (Biologics)

US-PA-West Chester
Requisition #
17-19358
# Positions
1
Category
Research & Development - Pharmaceutical

Overview

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.

Responsibilities

  • 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

Qualifications

  • 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.

 

Preferred:

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

 

 

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