Home Find Jobs in Higher Ed Receive Job Alerts Post Resume/CV Events Video Contact About Employers  
 
Job Seekers
Create Free Account
Post Resume/CV
Find Jobs
Receive Jobs by Email
 
 
Employers
Post Jobs
Post Events
Post Banner Ads
Purchase Job Packs
 
 
Features
Videos
Events
Announce Events
Announce New Hires
 
 
 
 
 
 
 
Director, Head of Toxicology
CSL Behring in King of Prussia, Pennsylvania
 
 
Save Print Apply
 
Date Posted October 19, 2019
Category
Science-Life Sciences
Employment Type Fulltime
Application Deadline Open until filled
 
 
 

As Director, Head of the Toxicology, this role is managing a group of non-clinical pharmacology and toxicology experts. Together, this team is responsible for developing the non-clinical toxicology strategy of CSLs drug development candidates from early range finding and mechanistic studies to definitive GLP toxicology programs. The incumbent will be responsible for the design, adequate budgeting and monitoring of non-clinical safety studies conducted internally and externally both in a GLP and non-GLP environment followed by the interpretation, communication and reporting of non-clinical safety data generated. The incumbent will liaise closely with global cross-functional project teams and interact with regulatory health authorities and external experts.

RESPONSIBILITIES AND ACCOUNTABILITIES :

  • Manage a gloabl team of senior managers, managers and technical staff

  • Develop toxicology strategies and provide toxicological expert support to research and development projects.

  • Serve as function’s representative across activities in the area protein drug and gene therapy development.

  • Manage and coordinate internal and external toxicology studies as part of global teams.

  • Prepare the non-clinical contribution of national and international regulatory submissions.

  • Oversee the toxicology activities across CSLs R&D portfolio

  • Take responsibility as preclinical project lead for selected research or development projects.

  • Oversee and manage toxicology programs along clinical development up to marketing and life cycle management.

  • Plan, monitor, analyze and report preclinical pharmacology and toxicology studies conducted internally or in collaboration with external contract research organizations (CROs) for selected projects.

  • Manage and prepare toxicological risk assessments to support drug development and manufacturing.

  • Actively collaborate with global, cross-continental project teams.

  • Participate in CSLs safety and project governance committees

  • Support the preclinical evaluation of external assets and in-licensing opportunities

  • Manage the assigned functional budget

  • Support improvement initiatives to enhance efficiency and quality of the group's deliverables.

  • Maintain a high level of awareness of scientific developments and the competitive environment to assist on ongoing strategic re-evaluation of ongoing programs.

  • Actively establish and foster a high quality, global network with relevant experts internally and externally

 

JOB SPECIFICATIONS

Education

  • Advanced degree (PhD, MD, PharmD) in Life Sciences or closely related fields

  • Toxicology training, board certification preferred

Experience

  • At least 10 years of experience within the pharmacology and toxicology are in a biotechnology, pharmaceutical or CRO setting with proven track record.

  • In depth experience in protein drug development

  • Management of global teams and budgets

  • In depth knowledge of relevant regulatory guidelines.

  • Strong scientific background in at least one of the following therapeutic areas: hematology, immunology, transplantation, cardiovascular disease, pulmonology.

  • Additional experience in development of gene therapies, RNA based therapies and/or small molecules of advantage

Travel Requirements

  • Occasional domestic and international travel required.

 

Worker Type:

Employee 
Worker Sub Type:

Apply
*Please mention AllHigherEd to employers when applying for this job*
 
 
 
 
 
AllHigherEd
Academic Advertising
260 Peachtree Street, N.W.
Suite 2200
Atlanta, GA 30303
 
Twitter
LinkedIn
Facebook
Google Plus
 
About AllHigherEd
Advertise Jobs
Contact Us
 
Site Map
Privacy Policy
Terms of Use
Copyright © 2010 AllHigherEd - All Rights Reserved.