Study Director, Toxicology

RiseMe; Chicago (IL); On-site; USD 85,000 - 120,000; Full time

Benefits offered by this job

401k matching

Vision Insurance

Medical & Dental

FSA

Disability insurance

Life Insurance

Paid Holidays & PTO

Job summary

Frontage Laboratories Inc. is seeking a Study Director – Safety and Toxicology to lead nonclinical toxicology studies for regulatory submissions at our Chicago site.

You will oversee GLP toxicology studies, including acute, sub-chronic and chronic work, and ensure accurate data interpretation and reporting. Reporting to the VP of Toxicology, you will interact with internal teams and external clients, manage multiple projects, and provide expert consultations on IND enabling studies, with a

Qualifications

• PhD in toxicology or related subject; DABT certification preferred but not required.
• Relevant experience may be accepted in place of a PhD.
• Master’s with 2+ years of relevant scientific experience.
• Bachelor of Science with 5+ years of relevant scientific experience.
• Strong written and verbal communication and multitasking across disciplines.
• Thorough understanding of GLP regulatory requirements and IACUC knowledge.

Responsibilities

• Perform responsibilities as a Study Director for regulatory studies, including design, protocol development, and data reporting in GLP.
• Stay current with Safety and Toxicology study designs and techniques.
• Prepare study methodologies and SOPs as needed.
• Provide expert consultations to clients on IND enabling toxicology studies.

Skills

Leadership

GLP knowledge

Toxicology studies

Regulatory submissions

Client interaction

Data analysis

Communication

Education

PhD in toxicology

DABT certification

Masters in science

Bachelors in science

Tools

Microsoft Excel

Microsoft Word

PowerPoint

Job description

Study Director

Title: Study Director;Toxicology

Location: Chicago, IL (on-site)

Reporting to: VP of Toxicology

Full-time

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 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.

Our Chicago, IL site provides toxicology testing and research laboratory services and specialized pre‑clinical studies in support of pharmaceutical and biotechnology products.

We have an excellent career opportunity for a Study Director – Safety and Toxicology to join our dynamic team in Chicago!

Position/Job Summary

This position is fora Study Director within the Safety and Toxicology department at Frontage, specifically to perform duties related to directing nonclinical Toxicology studies in as Study Director for regulatory submissions. The person will serve as the Study Director for Toxicology Studies, including Non-GLP MTD/DRF, and Acute, Sub-Chronic and Chronic GLP Toxicology Studies as described. They have overall responsibility for the technical conduct of a study as well as for the interpretation, analysis, documentation, and reporting of results. Activities also include productive interactions with management, technical staff, global internal and external clients, and study direction staff.

Roles & Responsibilities

• Perform responsibilities as a Study Director for regulatory and exploratory toxicology studies, including study design and protocol development, as well as data evaluation and reporting in compliance with GLPs.
• Stay current with Safety and Toxicology study designs and techniques.
• Prepare study specific methodologies and SOPs, as needed.
• Trained in providing expert consultations to clients on IND enabling toxicology studies.

Education, Experience & Skills Required

• PhD in toxicology or related subject, DABT certification preferred but not required.
• Relevant experience may be accepted in place of a PhD.
• Masters with 2+ years of relevant scientific experience.
• Bachelor of Science with 5+ years of relevant scientific experience.
• The ability to work across multiple disciplines and to manage multiple projects simultaneously is highly desirable.
• Effective written and verbal communication skills required.
• Thorough understanding of GLP regulatory requirements, and various toxicology testing guidelines.
• Knowledge of standard operating procedures and IACUC requirements.
• Demonstrated leadership skills, experience with client interactions and business development.
• Proficiency in the use of standard software including Microsoft Excel, Word, PowerPoint, etc. and with standard laboratory calculations.
• The company offers a competitive package of benefits including health insurance, 401K Plan and profit-sharing.

Salary

$85K-$120K, negotiable based on qualification and experience

Benefits

• 401k Employer Match with immediate vesting
• Vision Insurance
• Medical and Dental Insurance with multiple coverage options
• FSA (Medical, Dependent Care, and Commuter)
• Short Term Disability
• Long Term Disability
• Life Insurance
• Generous Paid Holidays and PTO

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.