This is where you save and sustain lives At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare. Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work. Join us at the intersection of saving and sustaining lives- where your purpose accelerates our mission. 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 commu ication 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). 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 $152,000 to $209,000 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. Join us as we revolutionize the treatment landscape and help improve patient lives worldwide. Baxter plans to spin off our $5B Kidney Care segment into an independent, publicly traded company. The new standalone entity will leverage 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. With its own investment priorities and enhanced management focus, the company will be better positioned to pursue growth opportunities and invest in innovation. We will build on our leadership in the kidney care space, fueled by our steadfast focus on innovation, our passion for patients and their families and our expertise in operational excellence. This is where you can make an impact. 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. 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 here and let us know the nature of your request along with your contact information. Recruitment Fraud Notice Baxter has discovered incidents of employment... For full info follow application link. 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