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Associate Director, Preclinical Toxicology

Req #: JR - 121075 Location: Plymouth, Minnesota, United States Job Category: Research and Development Date posted: 04/12/2024

Overview

This is where new knowledge is discovered. Baxter’s Research and Development teams work cross functionally to innovate, develop and introduce creative solutions for patients needs globally. From Scientists to Engineers, your work creates the products that save and sustain lives

  • Support for Parents

  • Continuing Education/
    Professional Development

  • Employee Health &
    Well-Being Benefits

  • Paid Time Off

  • 2 Days a Year to Volunteer

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Success Profile

What makes a successful Research and Development team member at Baxter? Take a look at some of the top traits we’re looking for and see if you’re a fit.

  • Courage
  • Action Oriented
  • Collaborates
  • Cultivates Innovation
  • Manages Ambiguity
  • Drives Results

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Associate Director, Preclinical Toxicology

Vantive: A New Company Built On Our Legacy

Baxter is on a journey to separate our ~$5B Kidney Care segment into a standalone company. Vantive* will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us.

At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us are driven to help improve patients’ lives worldwide. Join us as we revolutionize kidney care and other vital organ support.

*Completion of the proposed separation of Kidney Care from Baxter into a standalone company (to be named Vantive) remains subject to the satisfaction of customary conditions.

Your Role:

The Associate Director of Preclinical (Toxicology and biocompatibility) will support a portfolio of drug, medical device, drug packaging system, and/or combination product development and global registration. This individual will apply expertise and in-depth applied knowledge of toxicology, biocompatibility, and related scientific knowledge to find innovative solutions to develop nonclinical regulatory strategies, solve technical challenges and move new product development and product support projects forward. 

The Associate Director will develop and author responses to regulatory agencies and be willing to challenge the status quo. The successful candidate in this role will be expected to mentor internal colleagues in nonclinical (toxicological) risk assessment, and work with external partners, scientific societies and regulators globally.  This is an opportunity to become part of a highly matrixed multidisciplinary team that is responsible for ensuring the safety of both drugs and medical devices. The role will report to Director of Preclinical and Toxicology assessment team responsible drugs and devices for Peritoneal dialysis, Hemodialysis, and Acute therapies (~$5B product portfolio with global reach in more than 100 countries). The successful candidate will lead a small team of preclinical scientists.

What You Will Be Doing:

  • Independently authors and conducts qualitative or quantitative toxicological risk assessments to support of biological evaluation of drug, medical devices and/or combination products.
  • Independently develops and authors preclinical regulatory submission content for CTD and DHF files, US FDA, EU and other national or global submissions.
  • Independently develops and authors responses to submission deficiencies/questions (e.g., 510K, PMA, EU MDR).
  • Aids in study design of Extractable & Leachable studies and monitoring of GLP safety studies for drug and medical device qualification.
  • Provides support to manufacturing in change control initiatives and safety evaluation as required.
  • In addition to having an in-depth knowledge and understanding of GxP and related regulations and guidance (e.g., ISO 10993-1, ISO 10993-17, ISO 10993-18, ICH, OECD TGs), provides experienced insights into such regulations so as to facilitate efficient product registration and/or is an active participant in the generation, review, adoption and interpretation of such regulations.
  • Independently plans, implements and leads projects/programs that both span multiple fields and apply established methods, techniques or approaches.
  • Independently reviews literature and identifies relevant information to support product development and registration.

What You Will Bring:  

  • In-depth applied knowledge of ISO 10993-1, ISO 10993-17 and ISO 10993-18 required.
  • Must possess a working knowledge of toxicology and preclinical regulatory requirements as they relate to the development and registration of medical devices and an eagerness to learn and develop scientific competence beyond their current skills.
  • Experience authoring Toxicological Risk Assessments and deriving Tolerable Intake values, Margin of Safety and Analytical Evaluation Thresholds.
  • Shown technical writing ability and oral presentation to enable clear communication of study results, safety evaluations, and toxicology assessment conclusions.
  • Ability to work independently and prioritize assignments to meet project schedules.
  • Can effectively collaborate in a global team, including ability to work with individuals of diverse scientific and cultural backgrounds across multiple business units as well as with external partners/CROs.
  • Demonstrates flexibility and the ability to lead junior colleagues and coordinate multiple projects comfortably.

What You Need:   

  • Degree in toxicology, pharmacology, chemistry or other related scientific field, with the following minimum previous experience working in the pharmaceutical/medical device industry in GLP/GMP environments:
    • MS degree with 10+ years of relevant experience
    • PhD with 8+ years of relevant experience
  • Proven experience with the conduct and execution of GLP nonclinical safety (toxicology) and toxicological risk assessment on Extractable & Leachable is highly preferred.
  • Toxicology Board Certification is highly desired (DABT or ERT)
  • Experience with safety and biocompatibility evaluation of medical devices and related regulatory guidance (USP, ISO 10993, EU MDR, etc).

Baxter is committed to supporting the needs for flexibility in the workplace. We do so through our flexible workplace policy which includes a minimum of 3 days a week onsite. This policy provides the benefits of connecting and collaborating in-person in support of our Mission.

We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $168,000 - $231,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on upon location, skills and expertise, experience, and other relevant factors. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.

The successful candidate for this job may be required to verify that he or she has been vaccinated against COVID-19, subject to reasonable accommodations for individuals with medical conditions or religious beliefs that prevent vaccination, and in accordance with applicable law.

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

EEO is the Law 
EEO is the law - Poster Supplement
Pay Transparency Policy

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

Recruitment Fraud Notice

Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.

121075

Hear from Our Employees

Our company is enriched by a diverse population of individuals in more than 100 countries that work to solve, innovate, manufacture and drive better healthcare options for patients around the world.

Meet Reagan, Senior Research Scientist in the United States

For me, the best thing about working at Baxter is being able to do work that’s important to people—especially patients—outside of Baxter's walls. Inside our walls, I get to work with a fantastic team, and we know we're making a difference.

Reagan

Meet Karthik, Director of Renal Care R&D - Digital Health & Co-President of the Asian Leadership Network Business Resource Group, United States

I’m excited about my role because I believe that digital initiatives can make a tremendous impact on lives by allowing people to access the same therapies and have similar care — whether in a hospital, a healthcare clinic, or the patient’s home — anywhere in the world.

Karthik

Meet Amitha, Research Associate in India

Coming from a non-healthcare academic background, my current role has offered ample opportunities to learn a lot of new things. Leaders at Baxter are motivating, help us grow and provide a collaborative environment. The role gives me opportunities to have technical discussions with peers and subject matter experts globally, to learn interacting with customers, and manage project deadlines and deliverables. I am excited about shaping my career here at Baxter

Amitha

Hear from Our Employees

Our company is enriched by a diverse population of individuals in more than 100 countries that work to solve, innovate, manufacture and drive better healthcare options for patients around the world.

Reagan

Meet Reagan, Senior Research Scientist in the United States

For me, the best thing about working at Baxter is being able to do work that’s important to people—especially patients—outside of Baxter's walls. Inside our walls, I get to work with a fantastic team, and we know we're making a difference.

Karthik

Meet Karthik, Director of Renal Care R&D - Digital Health & Co-President of the Asian Leadership Network Business Resource Group, United States

I’m excited about my role because I believe that digital initiatives can make a tremendous impact on lives by allowing people to access the same therapies and have similar care — whether in a hospital, a healthcare clinic, or the patient’s home — anywhere in the world.

Amitha

Meet Amitha, Research Associate in India

Coming from a non-healthcare academic background, my current role has offered ample opportunities to learn a lot of new things. Leaders at Baxter are motivating, help us grow and provide a collaborative environment. The role gives me opportunities to have technical discussions with peers and subject matter experts globally, to learn interacting with customers, and manage project deadlines and deliverables. I am excited about shaping my career here at Baxter

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