Study Director, Developmental and Reproductive Toxicology (DART)
Frontage Laboratories
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.
Job description
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.
Requirements
- 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
- Ability to work across multiple disciplines and manage multiple projects simultaneously
- Effective written and verbal communication skills
- 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 standard software including Microsoft Excel, Word, PowerPoint, etc. and standard laboratory calculations
Benefits
- 401(k) Matching
- Profit Sharing
- Medical Insurance
- Dental Insurance
- Vision Insurance
- FSA
- Short Term Disability
- Long Term Disability
- Life Insurance
- Paid Holidays
- PTO
Company overview
Frontage Laboratories is a leading global Contract Research Organization (CRO) established in 2001 and headquartered in Exton, Pennsylvania. As an FDA-registered and inspected pharmaceutical development organization, Frontage provides comprehensive, science-driven services throughout the entire drug discovery and development lifecycle. The company operates 26 state-of-the-art facilities across North America, Europe, and Asia, serving biotechnology and pharmaceutical clients of all sizes. Frontage's integrated service portfolio includes drug discovery, drug metabolism and pharmacokinetics (DMPK), preclinical safety and toxicology, formulation development and manufacturing, analytical and bioanalytical testing, clinical trials, and central laboratory services. With over 1,800 employees worldwide, the company has established itself as a strategic partner in advancing innovative therapies from early discovery through regulatory submissions and commercialization. Frontage's expertise spans small molecules, biologics, cell and gene therapies, and agrochemicals, supported by GLP/GCP-compliant operations and a robust quality assurance framework that enables clients to navigate complex regulatory pathways in the US, EU, China, and other global markets.