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Associate Director, Toxicology

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Location
Irvine, CA
Salary
$100,000 - $150,000
Job Type
Direct Hire
Date
Apr 29, 2017
Job ID
2395387
Assoc Dir, Toxicology  
Top tier global pharmaceutical company and a leader in a new industry model – Growth Pharma focused on developing, manufacturing and commercializing branded pharmaceuticals and biologic products for patients around the world.
Company markets a portfolio of best-in-class products that provide novel treatments for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology, anti-infective and cardiovascular therapeutic categories. With commercial operations in approximately 100 countries, Company is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives.
  
The Associate Director, Toxicology is responsible for all nonclinical activities pertaining to drug discovery, drug development, regulatory, and marketing commitments and provides leadership and support to various department initiatives and project issues. Additional responsibilities include nonclinical aspects of due diligence assignments to determine toxicity and safety of potential partner or acquisition compounds.
 
Main Areas of Responsibilities
  • Responsible for providing non-clinical support to in-licensing review teams and product development teams.
  • Design non-clinical development plans to support drug development programs.
  • Analyze and interpret non-clinical data/study results.
  • Prepare non-clinical sections of regulatory submissions (e.g. INDs, NDAs) and responses to questions from global health authorities.
  • Represent Company to partner companies.
  • Represent Company and product development teams at meetings with global health authorities.
  • Responsible for using electronic tools (e.g. DEREK) and for performing literature searches.
  • Support review and revision of SOPs.
  • Collaborate with consultants, key contacts and experts in the field, as necessary.
  • May interact with Contract Research Organizations (CROs).
  
Requirements
 
The following listed requirements need to be met at a minimum level to be considered for the job:
  • 8+ years industry-related experience in Toxicology working within the pharmaceutical industry. 
  •  Familiarity with global regulatory requirements for drug development and GLP regulations.
Education
  • Ph.D. (or equivalent) in Toxicology or related discipline required.