Study Director, Developmental and Reproductive Toxicology (DART)

Posted 10 Days Ago
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Chicago, IL, USA
In-Office
95K-130K Annually
Senior level
Healthtech • Biotech • Pharmaceutical
The Role
Direct nonclinical developmental and reproductive toxicology studies for regulatory submissions, including embryo-fetal development, fertility, pre/postnatal, and juvenile studies. Responsibilities include study design, protocol development, GLP compliance, data evaluation, pathology review, reporting, SOP development, client consultation, and technical leadership. The role requires collaboration across scientific disciplines and management of multiple projects.
Summary Generated by Built In

Study Director

 

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 for a 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.

 

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 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, 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.

 

Skills Required

  • PhD in toxicology or a related subject, or equivalent relevant experience
  • Master's degree with at least 2 years of relevant scientific experience
  • Bachelor of Science degree with at least 5 years of relevant scientific experience
  • Understanding of GLP regulatory requirements and toxicology testing guidelines
  • Knowledge of standard operating procedures and IACUC requirements
  • Effective written and verbal communication skills
  • Proficiency with Microsoft Excel, Word, PowerPoint, and standard laboratory calculations
  • DABT certification
  • Ability to work across multiple disciplines and manage multiple projects simultaneously
  • Leadership, client interaction, and business development experience

Frontage Laboratories, Inc Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Frontage Laboratories, Inc and has not been reviewed or approved by Frontage Laboratories, Inc.

  • Healthcare Strength — Health insurance is often described as good or affordable, with medical, dental, and vision consistently included. Feedback suggests this coverage stands out as a solid element of the package.
  • Retirement Support — A company‑matched 401(k) is frequently mentioned and at times characterized as competitive. Access to retirement savings with an employer match is viewed as a meaningful benefit.
  • Leave & Time Off Breadth — PTO is offered with floating holidays and some carryover, with reports of about three weeks to start in certain roles. These features indicate a reasonably comprehensive time‑off structure.

Frontage Laboratories, Inc Insights

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The Company
HQ: Exton, PA
591 Employees
Year Founded: 2001

What We Do

Frontage Laboratories, Inc. is a CRO that provides integrated, science-driven, product development services throughout the drug discovery and development process to enable pharmaceutical and biotechnology companies to achieve their development goals. Comprehensive services include drug metabolism and pharmacokinetics, analytical testing and formulation development, preclinical and clinical trial material manufacturing, bioanalysis, preclinical safety and toxicology assessment and early phase clinical studies. Frontage has enabled many biotechnology companies and leading pharmaceutical companies of varying sizes to advance a myriad of molecules through development and file regulatory submissions in the United States, China and other countries.

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