Employer: Create Account or Login
Sign In
 [New User? Sign Up]
Mobile Version

Associate Director Bioanalytical PK/PD Biomarker (Biologics)

Teva Pharmaceuticals


Location:
Modena, PA
Date:
12/12/2017
2017-12-122018-01-10
Job Code:
17-19358
Apply on the Company Site
  •  
  • Save Ad
  • Email Friend
  • Print
  • Research Salary
Careercast Networks
  • Diversity
  • Disability

Job Details

Careers - Teva Pharmaceuticals in the US -Associate Director Bioanalytical PK/PD Biomarker (Biologics)

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.

 

Pred:

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

 

 

#LINKEDIN

Options

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

Connect With Us!

Not ready to ? Connect with us for general consideration.
Apply on the Company Site

Join us at the forefront of pharmaceutical research and production. With state-of-the-art facilities, highly skilled colleagues, and a high-powered organizational culture, Teva offers you countless possibilities to make a real difference in people's lives and add value to your career.

Powered ByLogo

Featured Job

Featured Employer

© Adicio Inc.