Project Toxicologist F/M

Tasks

AIXIAL is part of the ALTEN group and has been for the past 12 years an International Contract Research Organization providing clinical trial services to its clients in the pharmaceutical, medical devices, biotechnology, nutritional & cosmetics industries.

 

One of our clients is recruiting a Project Toxicologist (CDI) who will be based either in their offices next to Paris or in Montpellier.

 

Your missions : 

 

1-Provide preclinical safety expertise for the evaluation of potential [mutagenic] impurities in marketed products according to ICH guidelines (mainly ICH M7 but also ICH Q3A/B), and in accordance with our company policy.

The roles will be to:

 

  1. Represent Preclinical safety function (Toxicology), in  the multi-functional (international) teams
  2. Collaborate with the preclinical safety colleagues (in silico and genetic toxicology) in order to get the toxicity and mutagenicity hazard assessment done
  3. Collect and analyze the relevant information for the impurity risk characterization
  4. Make sure that the necessary follow-up testing is performed to further characterize the risk, when needed
  5. Contribute to the preparation of regulatory documentation.

 

 

2-Provide preclinical safety expertise for Consumer Health Care (CHC) projects/products

  1. Represent Preclinical safety function (Toxicology), in  the multi-functional (international) teams
  2. Contribute to the preparation of regulatory documentation (CTA, CTD, Marketing Authorization renewal)
  3. Provide toxicology assessment (eg on excipients) when requested

 

 

 

Main internal interfaces will be:

  1. Under the supervision of senior PS-Dedicated Project Expert
  2. In silico and genetic toxicology teams and Scientific Advisor in genetic toxicology with preclinical safety in France and Germany
  3. Global and local regulatory Affairs, Analytical Sciences, Chemical Development, Industrial Affairs within multifunctional (international) teams

 

 

 

Requirements

Knowledge in :

-Toxicology (preferably including genetic toxicology background).

-Knowledge on regulatory requirements (preferably for pharmaceuticals). 

-Ability to work in multifunctional and international teams.

-English oral and written communication skills (international teams),

-Ability to articulate scientific and tactical options.

 

MD, PharmD and/or PhD in toxicology, or related fields. A minimum of 3-4 years experience in preclinical safety in industry (preferably in pharmaceutical industry and with some experience as project team member). 

Experience in managing and addressing preclinical safety issues (especially genetic toxicology) and in authoring the preclinical safety sections of regulatory documents.