Manager - Toxicology Operations - Remote

Regeneron Pharmaceuticals
$114,800 - $187,400Remote

About The Position

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Toxicology Operations Manager to join our Toxicology team, leading scientific, technical, and operational tasks as assigned to support toxicology program representatives and toxicology department leadership. In this role, you will independently manage and be responsible for the contracting, drug supply, protocol development, and conduct of non-GLP and GLP Toxicology studies through remote and on-site CRO monitoring. The individual will also contribute to the review and evaluation of study data providing program toxicologists with data summaries to enable alignment on study results. The individual will also contribute outside of the Toxicology department presenting study results to preclinical subteams and global project teams as required. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

Requirements

  • Bachelor’s or Master’s degree in biological sciences with more than 7 years of post-degree experience within a pharmaceutical/drug development environment.
  • Significant experience in the design, monitoring and interpretation of regulated nonclinical safety studies.
  • Knowledge of communicating Toxicology study results up to the level of global project teams.
  • Ability to trouble-shoot challenges arising during the conduct of Toxicology studies

Responsibilities

  • Serves in a principal operational role for the Toxicology department, ensuring assigned department and project goals are achieved as assigned
  • Assists in defining standard departmental practices (including SOPs) for the conduct and reporting of Toxicology studies
  • Serves as the lead study monitor or sponsor representative with administrative oversight related to the conduct of Toxicology studies conducted at CRO
  • Collaborates with lead scientists providing direct input and suggestions on study designs and protocols
  • Responsible for independent coordination of study outsourcing (RFP, contracting, protocol development, monitoring, and reporting)
  • Provides detailed evaluation of experimental data from Toxicology studies and aligns with program toxicologists to interpret, report and present results
  • Assists/Directs the collection and evaluation of metrics associated with the conduct of Toxicology studies
  • Provides toxicology leadership assistance in regulatory inspection readiness activities

Benefits

  • health and wellness programs (including medical, dental, vision, life, and disability insurance)
  • fitness centers
  • 401(k) company match
  • family support benefits
  • equity awards
  • annual bonuses
  • paid time off
  • paid leaves (e.g., military and parental leave)
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