Manager - Toxicology Operations - Remote

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.

When & where:

Location – Full Time - Remote position with occasional International and Domestic travel.

Discover your role:

This role might be a fit for you,

• 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

This role requires:

• 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

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. 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, and 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. If you have any questions, please speak with your recruiter.

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)

Originally posted on Himalayas