Associate Manager, Toxicology Operations

Regeneron Pharmaceuticals, Inc.; United States; Hybrid; USD 98,000 - 160,000; Full time

Benefits offered by this job

Annual bonuses

Equity awards

Pension benefits

401(k) company match

Health & wellness programs

Fitness centers

Insurance benefits

Paid time off

Family support

Job summary

Regeneron Pharmaceuticals, Inc. in the United States is seeking an Associate Manager, Toxicology Operations to support the Toxicology department. You will monitor outsourced GLP and non-GLP studies, develop study concepts, and coordinate all logistical aspects of studies.

The role requires a biology degree with 6-8+ years in pharma/drug development, strong toxicology knowledge, and the ability to lead junior staff, with remote work option and EST hours preferred.

Qualifications

• Bachelor's degree in biological sciences with 6-8+ years post-degree experience in pharmaceutical/drug development.
• Strong understanding of toxicology investigations and regulated nonclinical safety studies.
• Experience designing, monitoring and interpreting toxicology studies and study concepts.

Responsibilities

• Lead operational role for the Toxicology department, directing junior specialists with minimal supervision.
• Collect and maintain metrics for toxicology studies (timelines, costs, etc.).
• Maintain department SOPs database.
• Lead study monitor on GLP toxicology studies and contribute to study design concepts.
• Coordinate all logistical aspects of outsourced studies.
• Develop protocols for outsourced toxicology studies with limited supervision.
• Monitor studies remotely or on-site at CRO to ensure protocol compliance.
• Review toxicology study data/reports and identify areas for further evaluation.
• Participate in department meetings to discuss operational strategies.

Education

Bachelor's degree in biological sciences

Master's degree preferred

Job description

Build Our Future Together

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases.

As an Associate Manager, Toxicology Operations you will be utilizing your broad foundation in drug development obtained through academic training and industry experience to perform scientific, technical, and operational tasks with limited supervision to support the Toxicology department. You will contribute to toxicology studies and/or program development through study monitoring of outsourced non-GLP and GLP studies through remote and onsite CRO monitoring and other activities as assigned by their supervisor.

When & Where

This position is approved to be hired remotely in the United States; EST hours preferred. Can also sit on-site in Tarrytown, NY if desired.

Discover Your Role

• Serves in a lead operational role for the Toxicology department. Responsible for overseeing completion of assigned department goals/activities with minimal supervision and directs junior specialists in the completion of support activities
• Assists and or is responsible for the collection and maintenance of metrics associated with the conduct of Toxicology studies (timelines, costs, etc.)
• Responsible for maintenance of department SOPs database
• Capable of acting as lead study monitor on GLP toxicology studies and contributes to the development of study design concepts and protocols
• Independently coordinates all aspects of logistical support for outsourced studies
• Develops protocols for outsourced toxicology studies with limited supervision
• Independently conducts study monitoring remotely or on-site at CRO ensuring study conduct complies with approved protocols and amendments
• Provides initial review and summation of Toxicology study data/reports and recommends areas for further evaluation by supervisor or senior Toxicology staff
• Actively participates in department meetings providing input on operational strategies

This Role Requires

• Minimum of a Bachelor's degree in biological sciences with 6-8+ years of post-degree experience within a pharmaceutical/drug development environment; Master's degree preferred.
• A well-developed understanding of the theory and rationale that underlie methods used in toxicologic investigations
• Significant experience in the design, monitoring and interpretation of regulated nonclinical safety studies required
• Capable of communicating at all levels of drug safety and pharmacometrics

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or 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
• family support benefits

For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about on-site expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually) $98,100.00 - $160,100.00