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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 have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries’ specific benefits, please speak to your recruiter.
Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location.
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, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
Salary Range (annually)