Senior Toxicologist

BioSpace; Cambridge (MA); On-site; USD 129,000 - 210,000; Full time

Job summary

Regeneron is seeking a Senior Toxicologist to lead nonclinical development programs with guidance from a supervisor, applying GLP and FDA/ICH guidelines to design, conduct, interpret, and report toxicology studies in rodent and non-rodent models.

The role also involves authoring regulatory documentation for submissions, coordinating cross-functional teams, and staying current with scientific advances; onsite in the U.S. Salary range provided.

Qualifications

• Advanced degree (e.g. PhD, DVM) in pharmacology, toxicology or closely related biological science along with 3-5 years relevant pharmaceutical industry experience, or Masters Degree + 10 years relevant pharmaceutical industry.
• Experience designing, monitoring and interpreting non-clinical safety studies.

Responsibilities

• Represent toxicology on global research and development project teams communicating non-clinical safety assessment strategy.
• Coordinate cross-department execution of the experimental plan including program budgets, and timing of toxicology studies in relation to regulatory and clinical milestones.
• Work with study monitoring group to coordinate, design, monitor, and report toxicology and safety pharmacology studies at contract research organizations.
• Communicate toxicology study findings, including relevant interpretation, to project teams and management.
• Contributing to non-clinical sections of regulatory documents including IND and NDA submissions.
• Maintain currency with GLP regulations and ICH, FDA and EMEA non-clinical safety guidelines.
• Keep up with the latest scientific developments by reading the current literature and attending conferences.

Skills

GLP regulations

FDA/ICH nonclinical guidelines

Regulatory toxicology

Nonclinical safety

Scientific communication

Education

PhD in pharmacology or toxicology

DVM

Masters degree

Job description

The Senior Toxicologist utilizes their scientific expertise and regulatory experience to lead nonclinical development programs with guidance from her/his direct supervisor working effectively within cross-functional project teams. The Sr. Toxicologist will demonstrate a thorough understanding of GLP regulations and FDA/EMEA/ICH nonclinical safety guidelines to independently lead the design, conduct, interpretation, and reporting of regulatory toxicology and/or exploratory pharmacology/toxicology studies in rodent and non-rodent safety models. The Sr. Toxicologist will provide primary authorship of all regulatory documentation required for submission packages, demonstrating excellent problem solving and communication skills (written and verbal).

Experience with multiple therapeutic modalities preferred, including antibody, oligonucleotide, and genetherapy products.

Job Responsibilities

• Represent toxicology on global research and development project teams communicating non-clinical safety assessment strategy.
• Coordinate cross-department execution of the experimental plan including program budgets, and timing of toxicology studies in relation to regulatory and clinical milestones.
• Work with study monitoring group to coordinate, design, monitor, and report toxicology and safety pharmacology studies at contract research organizations.
• Communicate toxicology study findings, including relevant interpretation, to project teams and management.
• Contributing to non-clinical sections of regulatory documents including IND and NDA submissions.
• Maintain currency with GLP regulations and ICH, FDA and EMEA non-clinical safety guidelines.
• Keep up with the latest scientific developments by reading the current literature and attending conferences.
  

Job Requirements

• Advanced degree (e.g. PhD, DVM) in pharmacology, toxicology or closely related biological science along with 3-5 years relevant pharmaceutical industry experience, or Masters Degree + 10 years relevant pharmaceutical industry
• Experience in designing, monitoring and interpreting non-clinical safety studies.

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 onsite. Please speak with your recruiter and hiring manager for more information about onsite 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)

$128,600.00 - $210,000.00