About the role

Senior Research Scientist - Toxicologist at Baxter leading compliance and safety assessments for medical devices. Collaborating on innovative toxicology strategies within R&D and regulatory frameworks.

Responsibilities

Provide technical and strategic input to project teams, ensuring compliance with Baxter and external standards while driving business objectives.
Take the lead in authoring pre-clinical sciences and toxicology deliverables, including non-clinical testing plans and toxicological risk assessments, to support global programs.
Plan and manage complex projects, prioritizing workloads and meeting major organizational objectives in collaboration with senior management.
Assess technical and scientific information, identify deficiencies, and design innovative solutions to mitigate risks.
Support innovation initiatives by providing technical direction and ensuring the quality of deliverables that integrate state-of-the-science theory with practical approaches.
Participate in standards organizations and regulatory committees to influence emerging regulations based on sound scientific principles.
Work closely with R&D, Clinical, Medical Affairs, Regulatory Affairs, Quality, Manufacturing, and Environmental Health and Safety teams to support various projects and initiatives.
Articulate the Pre-Clinical Toxicology vision, goals, and performance to project teams, fostering a culture of high standards and stretch goals.
Establish and nurture professional networks both internally and externally, participating in global task forces and committees to exchange technical information.

A BS with 12+ years, MS with 10+ years, or PhD with 4 + years of relevant experience in R&D and/or GLP environments.
Medical Device experience strongly preferred.
Solid understanding of national and international non-clinical safety and biological evaluation regulations, including Good Laboratory Practices (GLP).
Direct experience working with regulatory bodies such as the US-FDA, EU Notified Bodies, and other national or international reviewers.
A strong track record of presenting at scientific conferences and authoring/co-authoring published articles in peer-reviewed journals.
Demonstrated ability to advance new product development projects and provide innovative non-clinical solutions for pharmaceutical and medical device challenges.
Experience in a GLP and/or R&D environment, with a solid understanding of project management principles.

medical and dental coverage that start on day one
insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP)
401(k) Retirement Savings Plan (RSP)
Flexible Spending Accounts
educational assistance programs
time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave
commuting benefits
Employee Discount Program
Employee Assistance Program (EAP)
childcare benefits