Associate Manager, Toxicology Operations

Regeneron Pharmaceuticals

3d • $98,100 - $160,100 • Remote

About The Position

The Associate Manager, Toxicology Operations uses a broad foundation in drug development gained through academic training and industry experience to perform scientific, technical, and operational tasks with limited supervision in support of the Toxicology department. The role contributes to toxicology studies and program development, including monitoring outsourced non-GLP and GLP studies remotely and onsite at contract research organizations (CROs).

Serving in a lead operational role, the Associate Manager oversees assigned department goals and activities, directs junior specialists in support activities, maintains study metrics and the department SOP database, and coordinates logistical support for outsourced studies. The role may act as lead monitor on GLP toxicology studies, develops study concepts and protocols, conducts CRO monitoring, reviews and summarizes study data and reports, and contributes to operational strategies in department meetings.

The position may be hired remotely in the United States, with EST hours preferred, or based onsite in Tarrytown, New York.

Requirements

• Bachelor's degree in biological sciences.
• 6–8+ years of post-degree experience in a pharmaceutical or drug development environment.
• Well-developed understanding of the theory and rationale underlying methods used in toxicologic investigations.
• Significant experience in the design, monitoring, and interpretation of regulated nonclinical safety studies.
• Ability to communicate at all levels of drug safety and pharmacometrics.

Nice To Haves

• Master's degree.

Responsibilities

• Oversee completion of assigned Toxicology department goals and activities with minimal supervision.
• Direct junior specialists in the completion of support activities.
• Collect and maintain metrics associated with Toxicology studies, including timelines and costs.
• Maintain the department SOP database.
• Act as lead study monitor on GLP toxicology studies and contribute to development of study design concepts and protocols.
• Coordinate all logistical support for outsourced studies.
• Develop protocols for outsourced toxicology studies with limited supervision.
• Conduct remote or onsite study monitoring at CROs to ensure studies comply with approved protocols and amendments.
• Provide initial review and summaries of Toxicology study data and reports, recommending areas for further evaluation by a supervisor or senior Toxicology staff.
• Participate in department meetings and provide input on operational strategies.

Benefits

• Competitive and comprehensive total rewards package, which may include annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, medical, dental, vision, life and disability insurance, paid time off, and family support benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager