FULL_TIME

FEED

UNKNOWN

Must be team oriented, with the ability to work well on common deliverables with diverse cross-functional teams and to interact at the highest professional manner with excellent communication skills, both verbal and written, and interpersonal skills to successfully partner on varying levels ranging from cross functional to global multi-site. This position ensures product safety and leads risk mitigation efforts in the form of biological evaluations, chemical characterization, and toxicological risk assessments for medical devices, OTC, and cosmetic products.

YEAR

<p style="text-align:left"><b>Job Summary</b></p>Serve as a subject matter expert, providing strategic guidance and scientific expertise to cross-functional teams, including R&D, quality, and regulatory affairs. This senior-level position requires deep expertise in toxicology, a strong understanding of international regulations, and excellent leadership skills. This position ensures product safety and leads risk mitigation efforts in the form of biological evaluations, chemical characterization, and toxicological risk assessments for medical devices, OTC, and cosmetic products. The role involves guiding product development teams and mentoring junior staff to ensure patient safety and product quality.<p style="text-align:inherit"/><p style="text-align:left"><b>Job Description</b></p><h2>Responsibilities:</h2><ul><li><h2>Provide strategic input for regulatory submissions (e.g., 510(k), CE marking, PMDA) and interact with global regulatory bodies.</h2></li><li><h2>Risk Assessment and Evaluation: Conduct and lead toxicological risk assessments for new and existing medical devices, components, and materials. This includes creating Biological Evaluation Plans (BEPs) and Biological Evaluation Reports (BERs) in accordance with ISO 10993 and responding to questions from regulatory agencies.</h2></li><li><h2>Develop and implement strategies for biological evaluation to ensure compliance with global regulatory standards, such as those from the FDA and EU MDR.</h2></li><li><h2>Stay current with emerging trends and advancements in the field of toxicology and product safety and integrate predictive toxicology tools into safety assessments.</h2></li><li><h2>Mentor and guide junior toxicologists and scientists, fostering technical growth and knowledge sharing.</h2></li><li><h2>Conduct and interpret chemical characterization (e.g., E&L studies, ISO 10993-18, ISO 18562), SAR/QSAR modeling, and guide biocompatibility testing under GLP requirements.</h2></li><li><h2>Serve as a subject matter expert, providing strategic guidance and scientific expertise to cross-functional teams, including R&D, quality, and regulatory affairs. Advise on potential risks and hazards associated with product materials and processes.</h2></li><li><h2>Independent problem solver who can use a methodical approach to develop solutions and make recommendations.</h2></li><li><h2>Represent the organization in external forums, regulatory meetings, and industry working groups (e.g., ASTM, ISO).</h2></li></ul><h2></h2><h2>Qualifications:</h2><ul><li><h2>Bachelor's degree in Toxicology, Pharmacology, or a related scientific field</h2></li><li><h2>10+ years of experience in toxicology, with a significant focus on medical devices or a closely related industry (e.g., pharmaceutical, biotech) and toxicological risk assessments, biocompatibility assessments, and chemical characterization.</h2></li><li><h2>In-depth knowledge of toxicology principles, risk assessment methodologies, and global regulations like ISO 10993, ISO 18562, ISO 14971, FDA, and EU MDR.</h2></li><li><h2>Must possess excellent communication (written and verbal), leadership, and problem-solving skills. The ability to manage multiple projects simultaneously and work effectively in a matrixed environment is critical.</h2></li></ul><h2></h2><h2>Preferred Qualifications:</h2><ul><li><h2>A Diplomate of the American Board of Toxicology (DABT) or equivalent certification is highly desirable.</h2></li><li><h2>Experience of quality audit by external regulatory bodies (FDA, EU Regulatory body, etc.).</h2></li><li><h2>Experience in solving practical problems and dealing with a variety of concrete variables in situations where only limited standardization exists.</h2></li><li><h2>Experience communicating with internal and external business partners and cross functional teams with various audiences.</h2></li><li><h2>Must be team oriented, with the ability to work well on common deliverables with diverse cross-functional teams and to interact at the highest professional manner with excellent communication skills, both verbal and written, and interpersonal skills to successfully partner on varying levels ranging from cross functional to global multi-site.</h2></li><li><h2>Self-starter, independent worker, detail oriented with critical thinking and excellent organizational, analytical and problem-solving skills.</h2></li><li><h2>Strong time management skills to prioritize, organize track details and meet deadlines for multiple projects with varying completion dates.</h2></li><li><h2>Ability to influence and motivate others to drive results in a multi-location and matrixed environment.</h2></li><li><h2>Ability to manage multiple projects in cross functional teams.</h2></li><li><h2>Comfortable in a dynamic environment and able to work independently as well as on teams.</h2></li></ul><p style="text-align:inherit"/><p style="text-align:left">Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization.</p><p style="text-align:inherit"/><p style="text-align:left">The anticipated salary range for this position:</p>$152,880.00 - $229,320.00 Annual<p/><p>The actual salary will vary based on applicant’s location, education, experience, skills, and abilities. This role is bonus and/or incentive eligible. Medline will not pay less than the applicable minimum wage or salary threshold.</p><p/><p>Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average. For a more comprehensive list of our benefits please click <a href="https://digital.alight.com/medline" rel="nofollow noopener noreferrer" target="_blank">here</a>. For roles where employees work less than 30 hours per week, benefits include 401(k) contributions as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp.</p><p/><p>We’re dedicated to creating a Medline where everyone feels they belong and can grow their career. We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best. Explore our Belonging page <a href="https://www.medline.com/about-us/belonging/" rel="nofollow noopener noreferrer" target="_blank">here</a>.</p><p/><p>Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws.</p><p/>

Medline Industries

Principal Toxicologist

Analysis Skills

Biotech and Pharmaceutical

Communication Skills

Concrete

Cross-Functional

Detail Oriented

Diversity

Employee Orientation

Establish Priorities

FDA (Food and Drug Administration)

GLP (Good Laboratory Practices)

ISO (International Organization for Standardization)

Interpersonal Skills

Leadership

Maintain Compliance

Medical Equipment

Mentoring

Multitasking

Organizational Skills

Patient Safety

Pharmacology

Presentation/Verbal Skills

Problem Solving Skills

Product Development

Product Safety

Project/Program Management

Regulations

Regulatory Compliance

Regulatory Submissions

Research & Development (R&D)

Risk Analysis

Risk Management

Strategic Analysis

Strategic Planning

Team Player

Test Requirements

Time Management

Toxicology

Trend Analysis

Writing Skills

Our Chicago, IL site provides services in general toxicology, developmental and reproductive toxicology (DART), juvenile and ocular toxicology in support of pharmaceutical and biotechnology products . Our core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials.

<strong>Job Title:</strong> Associate Director/Director of Toxicology <br/><strong>Location:</strong> Chicago, IL<br/><strong>Reports to:</strong> Vice President of Safety and Toxicology <br/><br/><strong>Full-time</strong><br/><br/>Frontage Laboratories Inc. is an award winning, full-service, CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada, Europe, and China. Our core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials. <br/><br/>Our Chicago, IL site provides services in general toxicology, developmental and reproductive toxicology (DART), juvenile and ocular toxicology in support of pharmaceutical and biotechnology products <br/><br/><strong>Position Summary</strong><strong>:</strong><br/>Frontage Laboratories is seeking an experienced and highly motivated Director of Toxicology with specialized expertise in Developmental and Reproductive Toxicology. This leadership role will be responsible for overseeing study design, execution, and interpretation of nonclinical toxicology studies, while managing and mentoring a team of scientists. The ideal candidate will bring strong scientific expertise, regulatory knowledge, and proven leadership experience within a CRO environment. <br/><br/><strong>Key Responsibilities</strong><strong>:</strong><br/><ul><li>Lead and oversee General Tox, Developmental and Reproductive Toxicology studies in compliance with GLP and regulatory guidelines </li><li>Provide scientific direction for study design, protocol development, and data interpretation </li><li>Serve as Study Director, as and when needed, or Senior Scientific Advisor on complex programs </li><li>Manage, mentor, and grow a team of Study Directors and scientific staff </li><li>Ensure high-quality deliverables, timelines, and client satisfaction </li><li>Interact with clients to provide scientific guidance and support business development efforts </li><li>Contribute to regulatory submissions and support audits/inspections (FDA, OECD, etc.) </li><li>Stay current with evolving regulatory requirements and scientific advancements </li></ul><strong>Qualifications</strong><strong>:</strong><ul><li>PhD in Toxicology or a related field </li><li>5-7 years of relevant experience in a reputable CRO or pharmaceutical/biotech setting </li><li>Demonstrated expertise in reproductive and developmental toxicology study design and interpretation </li><li>Experience serving as Study Director in GLP-compliant studies </li><li>Proven experience managing and leading scientific teams </li><li>Strong knowledge of regulatory guidelines (FDA, ICH, OECD) </li><li>Excellent communication, leadership, and client-facing skills </li></ul><strong>Preferred Qualifications</strong><strong>:</strong><ul><li>Board certification (e.g., DABT) is a plus </li><li>Experience supporting regulatory submissions (IND, NDA, etc.) </li><li>Track record of successful client engagement and project delivery </li></ul><strong>Salary</strong>: $140-160k, based upon experience <br/><br/><strong>Benefits:</strong><ul><li>401k Employer Match with immediate vesting </li><li>Vision Insurance </li><li>Medical and Dental Insurance with multiple coverage options </li><li>FSA (Medical, Dependent Care, and Commuter) </li><li>Short Term Disability </li><li>Long Term Disability </li><li>Life Insurance </li><li>Generous Paid Holidays and PTO </li></ul><br/><br/>Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.

Frontage Laboratories

Associate Director/Director of Toxicology

Business Development

Chemistry

Clinical Laboratory

Clinical Trial

Contract Research Organization (CRO)

Customer Relations

Customer Satisfaction

Drug Development

Drug Manufacturing

Drug Metabolism

FDA Requirements

ICH Regulations

Investigational New Drug (IND)

Laboratory

Life Insurance

Pharmacodynamics

Pharmacokinetics

Pre-Clinical Trials

Protocol Design

Regulatory Requirements

Team Lead/Manager

Toxicology Research

Hire Recruits

PART_TIME

More than 6,000 full-time students are enrolled in graduate programs in osteopathic medicine, dentistry, pharmacy, physician assistant studies, physical therapy, occupational therapy, nurse anesthesia, cardiovascular perfusion, podiatry, optometry, clinical psychology, speech language pathology, biomedical sciences and veterinary medicine. The successful candidate will be expected to participate in the delivery of team-taught pharmacology courses that meet the needs of several health care graduate programs, including osteopathic medicine, pharmacy, dentistry, optometry, biomedical sciences, physician assistant studies, and veterinary medicine.

<p>The Department of Pharmacology at Midwestern University, Downers Grove, IL, invites applications for a full-time, 12-month, tenure-track faculty position at the Assistant Professor level.  Applicants must possess a Ph.D. or equivalent degree in pharmacology or a closely related field, at least two years of post-doctoral experience, and a commitment to excellence in teaching and research.  The successful candidate will be expected to participate in the delivery of team-taught pharmacology courses that meet the needs of several health care graduate programs, including osteopathic medicine, pharmacy, dentistry, optometry, biomedical sciences, physician assistant studies, and veterinary medicine.  Applicants are expected to participate in course administration as well as service activities within the university and the general scientific community.</p><p>Applicants are expected to establish an independent research program capable of attracting extramural/NIH funding.  Field of research is open but ideally will complement ongoing departmental projects in the areas of neuropharmacology, toxicology, molecular pharmacology, cancer pharmacology, and cardiovascular pharmacology.  Support for research activities includes access to a core equipment facility with strengths in histology, confocal imaging, and molecular and analytical biology.  The MWU Animal Resource Facility is AAALAC accredited and the institution holds NIH R15 (REAP) eligibility status. Dedicated laboratory space and start-up funds are provided to support the candidate’s research endeavors</p><p>If you would like to learn more about this position, please submit your application through Midwestern University’s online job board at <a href="https://www.midwestern.edu/employment-mwu" rel="noopener nofollow noreferrer" target="_blank">https://www.midwestern.edu/employment-mwu</a>. </p><p>Your application packet should include:</p><ul><li>Cover letter</li><li>CV</li><li>Contact information for 3 references</li><li>Statement of teaching philosophy</li><li>Statement of research plan (< 3 pages)</li></ul><p>The search committee will begin reviewing applications immediately and will continue until the position is filled.  Applicants may send inquiries to: Marsha Pierce Ph.D., Department of Pharmacology, College of Graduate Studies, Midwestern University, 555 31st St., Downers Grove, Illinois, 60515, mpierc1@midwestern.edu.</p><p>Midwestern University is a private, not-for-profit organization that provides graduate and post-graduate education in the health sciences. The University has two campuses, one in Downers Grove, Illinois and the other in Glendale, Arizona. More than 6,000 full-time students are enrolled in graduate programs in osteopathic medicine, dentistry, pharmacy, physician assistant studies, physical therapy, occupational therapy, nurse anesthesia, cardiovascular perfusion, podiatry, optometry, clinical psychology, speech language pathology, biomedical sciences and veterinary medicine. Over 500 full-time faculty members and 400 staff members are dedicated to the education and development of our students in an environment that encourages learning, respect for all members of the health care team, service, interdisciplinary scholarly activity, and personal growth.</p><p>We offer a comprehensive benefits package that includes medical, dental, and vision insurance plans as well as life insurance, short/long term disability and pet insurance.  We offer flexible spending accounts including healthcare reimbursement and child/dependent care account.  We offer a work life balance with competitive time off package including paid holiday’s, sick/flex days, personal days and vacation days.  We offer a 403(b) retirement plan, tuition reimbursement, child care subsidy reimbursement program, identity theft protection and an employee assistance program.  Wellness is important to us and we offer a wellness facility on-site with a fully equipped fitness facility. </p><p><strong>Midwestern University is an Equal Opportunity/Affirmative Action employer that does not discriminate against an employee or applicant based upon race; color; religion; creed; national origin or ancestry; ethnicity; sex (including pregnancy); gender (including gender expressions, gender identity; and sexual orientation); marital status; age; disability; citizenship; past, current, or prospective service in the uniformed services; genetic information; or any other protected class, in accord with</strong><strong> all federal, state and local laws and regulation. Midwestern University complies with the Smoke-Free Arizona Act (A.R.S. 36-601.01) and the Smoke Free Illinois Act (410 ILCS 82/).  Midwestern University complies with the Illinois Equal Pay Act of 2003 and Arizona Equal Pay Acts.</strong></p>

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