Manager – Toxicology Study Director

Toxicology
Vadodara
Posted 9 months ago

This role requires relevant skills sets to toxicology pathology research and act as study pathologist for toxicity studies (acute, sub-acute, sub-chronic, chronic, reproduction, juvenile and carcinogenicity studies) in rodents and/or non-rodents.

What are the key responsibility of the role?

  • Monitoring, planning and designing regulatory and Non-Regulatory Toxicity and Safety Studies in Rodents and Non-Rodents Species.
  • To conduct long term toxicity studies (7/14/28/90 Days and 6 months) including carci study studies by different routes of administration viz. Oral (gavage), Intraperitoneal, Intravenous, Subcutaneous, Intramuscular, Intradermal, dermal application, Inhalation, Intra-tracheal, Intravaginal, etc. in rodents (rat, mouse, hamster, guinea pig) and non-rodents species (rabbit and dog).
  • To perform work in compliance with the OECD principles of Good Laboratory Practice.
  • Ethics Protocol, Study Plan, Standard Operating Procedure (SOP) and Formats for respective studies preparations as per GLP (Good Laboratory Practice).
  • Support in literature search for ongoing projects
  • Due diligence of in-licensing projects
  • Maintain instruments used routinely in toxicity studies as instrument in charge.
  • Training and mentoring of team members
  • Provide scientific inputs on matter related to toxicology
  • Lead discovery or similar projects, coordination with stakeholders and completion of task as per agreed timelines
  • To prepare and review SEND documents for different SEND domains for toxicity studies
  • To participate intra/inter departmental meetings, project review meetings and present/discuss data pertaining to toxicology
  • To provide administrative support to senior management team/department head
  • Preparation and review of IB, IND and NDA documents for regulatory submission

Key skills and requirement:

  • M. Sc. /M. Pharm /Ph. D with 8 to 14 years of relevant experience
  • Knowledge and experience of toxicity studies (acute, sub-acute, sub-chronic, chronic, reproduction, juvenile and carcinogenicity studies) in rodents and/or non-rodents.

 

 

Job Features

Job CategoryDrug Discovery & Preclinical Development
Job CategoryPartnerships & Portfolio Strategy

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