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Associate Director, Regulatory Toxicology

Norwood, MA 02062

Posted: 04/05/2019 Employment Type: Direct Hire Job Category: Clinical: Regulatory Job Number: 2300

The Associate Director, Regulatory Toxicology will work with internal cross-functional teams, external experts and regulators to support product discovery and development, and influence regulatory strategy, particularly with safety pharmacology and toxicology. This person will be responsible for designing in vitro or in vivo nonclinical toxicology/ research studies, analyzing study data, and addressing issues related to human safety. Further, this person will carry out strategies for ensuring that molecules are optimized with respect to safety before molecules are transitioned into clinical development. The person is also responsible for writing the safety pharmacology and toxicology sections of regulatory documents (IND/CTA/IB/NDA/MAA). This is a unique opportunity to make a big impact on a growing organization.

PRIMARY RESPONSIBILITIES:
  • Design, plan, prioritize and conduct experiments through CROs for safety pharmacology and toxicology or investigative studies of drug candidates in laboratory animals in support of client' s discovery and development programs.
  • Analyze and interpret the in vitro and in vivo study data, provide the project team on risk assessment and issue management, including support of clinical study protocol development for human safety and efficacy trials.
  • Manage existing CROs for safety pharmacology, toxicology and research studies
  • Review the study protocols and reports from CROs for the designated projects and ensure that all critical studies are completed with quality work and finalized for submission to regulatory agencies.
  • Write/review nonclinical sections to support regulatory (IND/CTA/IB/NDA/MAA) filings and provide response to regulatory queries related to safety pharmacology and toxicology data

  SKILLS & REQUIREMENTS:
  • Ph.D. or other equivalent field (such as DVM) with 5-7 years of relevant industry experience as a study director/monitor in toxicology
  • Experience specifically supporting drug discovery research and development from a toxicology standpoint
  • Experience in designing, conducting, monitoring and interpreting nonclinical toxicology/research studies.
  • Demonstrated success managing interactions with external CROs, consultants and other contract organizations is a plus.
  • Working knowledge of GLP regulations, ICH, and other regulatory guidance documents, and experience conducting and monitoring toxicology studies is critical.
  • Excellent organizational, interpersonal and verbal/written communication skills and ability to perform as an effective, flexible and self-assured team player.
  • Ability to thrive in a fast-paced, dynamic and entrepreneurial environment.
  • Certification by the American Board of Toxicology (DABT) highly desired.

Tracey Goldthwaite
Senior Vice President

Tracey has more than 20 years experience in the staffing and recruiting industry. She spearheads The Steely Group's Client Services efforts, ensuring superior customer service, communication, and ongoing support to clients and candidates alike. Additional areas of expertise include client relationship management and team building.
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