Study Director

Frontage Laboratories, Inc; Chicago (IL); On-site; USD 95,000 - 130,000; Full time

Benefits offered by this job

401k Plan with employer match

Vision Insurance

Medical and Dental Insurance

FSA (Medical, Dependent Care, and Comm

Long Term Disability

Life Insurance

Paid Holidays and PTO

Job summary

Frontage Laboratories, Inc. is seeking a Study Director for Developmental and Reproductive Toxicology (DART) to lead nonclinical studies and oversee regulatory submissions in Chicago.

The role emphasizes GLP compliance, cross-disciplinary leadership, and client interactions to ensure robust study conduct and reporting. The successful candidate will manage Embryo-fetal Development, Fertility, Pre-/Postnatal and Juvenile Toxicology studies, collaborating with global teams and external clients to

Qualifications

• PhD in toxicology or a related field; DABT preferred but not required.
• MS with 2+ years of relevant scientific experience.
• BS with 5+ years of relevant scientific experience.
• Ability to work across multiple disciplines and manage multiple projects.
• Excellent written and verbal communication skills.
• Thorough understanding of GLP regulatory requirements.
• Knowledge of SOPs and IACUC requirements.
• Demonstrated leadership and client interaction experience.
• Proficiency with Excel, Word, PowerPoint and standard lab calculations.

Responsibilities

• Direct nonclinical DART studies and regulatory submissions.
• Design study protocols, evaluate data and report results per GLPs.
• Stay current with DART study designs and techniques.
• Review external, visceral and skeletal fetal abnormalities.
• Prepare study-specific methodologies and SOPs as needed.
• Provide expert consultations to clients on DART study designs and timings.

Skills

Leadership

Client interactions

Study design

GLP knowledge

Communication

Microsoft Office

Education

PhD in toxicology

Master’s degree

Bachelor’s degree

Tools

Excel

Word

PowerPoint

Job description

Title: Study Director; Developmental and Reproductive Toxicology (DART)

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 – Developmental and Reproductive Toxicology (DART) to join our dynamic team in Chicago!

Position/Job Summary:

This position is fora Study Director within the Developmental and Reproductive Toxicology (DART) department at Frontage, specifically to perform duties related to directing nonclinical Developmental and Reproductive Toxicology (DART) studies as Study Director for regulatory submissions. The person will serve as the DART Study Director for Developmental and Reproductive Toxicology Studies, including Embryo-fetal Development, Fertility, Pre-/Postnatal and Juvenile Toxicology Studies as described in the GLPs. 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.

• 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 DART study designs and techniques and suggest ideas for technical development as appropriate.
• Considered a subject matter expert in one or more of the following: fetal pathology, endocrinology, behavioral toxicity/neurotoxicity, juvenile toxicity.
• Review and confirm external, visceral, and skeletal fetal abnormalities.
• Prepare study specific methodologies and SOPs, as needed.
• Trained in providing expert consultations to clients on customized DART study designs and study timings according to drug development needs.

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.
• Master’s 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: $95K-$130K, negotiable based on qualification and experience

• 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.