Manager - Toxicology Operations - Remote

About the role

The Toxicology Operations Manager 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. They will also contribute to the review and evaluation of study data, providing program toxicologists with data summaries to enable alignment on study results. Additionally, they will contribute to the presentation of study results to preclinical subteams and global project teams.

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

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

Qualifications

• Must be able to perform essential job functions with or without reasonable accommodation
• Must be able to travel domestically and internationally as needed

Skills

• Strong communication and collaboration skills
• Experience with CROs and contract management
• Proficiency in statistical analysis and data interpretation
• Excellent problem-solving and troubleshooting abilities

Benefits

Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits.

Pay

$114,800.00 - $187,400.00 annually

Schedule

Full time - Remote position with occasional International and Domestic travel.