Associate Director Toxicology in Whippany, New Jersey | DiversityInc Careers
 
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Associate Director Toxicology

.pre {white-space: pre-wrap;} Your tasks and responsibilities

The primary responsibilities of this role, Associate Director Toxicology, are to: 

  • Provide critical review and toxicology risk assessment reports in support of assigned projects;
  • Participate in multi-functional New Product Development (NPD) teams as a Toxicology representative to provide guidance on safety strategy for supporting new products and technologies;
  • Contribute to the design and execution of preclinical toxicology studies to support clinical trials and product registration for BCH’s global market;
  • Produce documents for Health Authorities for non-clinical purposes, e.g. CTD nonclinical modules and justification documents, with minimal guidance and supervision;

    Generate biocompatibility risk assessments for medical device products according to ISO (International Organization for Standardization) guidance;

  • Compile European Cosmetic Product Safety Reports (CPSR) following the appropriate regulation;
  • With guidance from PV BRM CH management, conduct evaluation on safety, toxicology, pharmacology and pharmacokinetics on external licensing candidates and Rx-to-Over the Counter switches;
  • Identify global product safety/regulatory trends, communicate their potential impact on New Product Development as well as BCH’s existing portfolio to leadership teams and evelop/implement appropriate corporate responses as necessary.

     

.pre {white-space: pre-wrap;} Who you are

Your success will be driven by your demonstration of our LIFE values.  More specifically related to this position, Bayer seeks an incumbent who possesses the following:

 

Required Qualifications:

 

  • Doctoral degree (e.g, Ph.D.)  in Toxicology, Pharmacology or a closely related field, and 6 or more years of relevant industry experience, or overall equivalent experience profile;
  • In depth knowledge of regulations and guidance’s administered by FDA, EMA, ISO, and European Commission on medicinal, medical device and cosmetic products;
  • Expertise in toxicology and risk assessment.

 

Preferred Qualifications:

 

  • Certified toxicologist (e.g. Diplomat of American Board of Toxicology) is preferred;
  • Experience in the Over the Counter drug industry, medical device and/or cosmetic industry is preferred.
.pre {white-space: pre-wrap;} Your application Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and you have the "Passion to Innovate" and the "Power to Change", we encourage you to apply now. Job postings will remain open for a minimum of ten business days and are subject to immediate closure thereafter without additional notice. To all recruitment agencies: Bayer does not accept unsolicited third party resumes.