Associate Manager, Toxicology Operations

atRegeneronRemoteUS flagUnited StatesFull-timeOperationsMid-level$98.1k – $160.1k/year

Posted 5 days ago

This is a fully remote position, open to applicants in United States.

📋 Description

• Leverage academic knowledge and professional expertise to execute scientific, technical, and operational tasks with minimal oversight.

• Provide support to the Toxicology department.

• Contribute to toxicology research and/or program development by monitoring both outsourced non-GLP and GLP studies.

• Perform remote and onsite monitoring of Contract Research Organizations (CROs).

• Take on a leadership role within the Toxicology department's operations.

• Ensure the successful completion of departmental objectives and activities with limited supervision.

• Guide junior specialists in their support tasks.

• Gather and maintain metrics related to Toxicology studies, including timelines and costs.

• Manage the department's Standard Operating Procedures (SOPs) database.

• Function as the lead study monitor for GLP toxicology studies.

• Contribute to the development of study design concepts and protocols.

• Coordinate logistical support for outsourced studies.

• Create protocols for outsourced toxicology studies.

• Monitor studies either remotely or onsite at CROs to ensure adherence to approved protocols and amendments.

• Review and summarize data and reports from Toxicology studies.

• Suggest areas for further evaluation by supervisors or senior Toxicology personnel.

• Engage in departmental meetings and offer input on operational strategies.


⛳️ Requirements

• A minimum of a Bachelor's degree in biological sciences.

• 6-8+ years of experience post-degree within a pharmaceutical or drug development setting.

• Strong understanding of the theories and principles behind methods used in toxicologic investigations.

• Extensive experience in the design, monitoring, and interpretation of regulated nonclinical safety studies.

• Ability to communicate effectively at all levels concerning drug safety and pharmacometrics.

• A Master's degree is preferred.


🏝️ Benefits

• Annual bonuses or other incentive plans.

• Equity awards.

• Pension or retirement benefits.

• 401(k) company match.

• Health and wellness programs.

• Access to fitness centers.

• Medical, dental, vision, life, and disability insurance benefits.

• Paid time off.

• Family support benefits.

• Reasonable accommodations during the recruitment process when necessary.

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