Study Director, Toxicology
Frontage Laboratories
Summary
This position is for a Study Director within the Safety and Toxicology department at Frontage, specifically to perform duties related to directing nonclinical Toxicology studies 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. 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.
Job description
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.
Requirements
- 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
- Ability to work across multiple disciplines and manage multiple projects simultaneously
- Effective written and verbal communication skills
- Thorough understanding of GLP regulatory requirements
- Knowledge of various toxicology testing guidelines
- Knowledge of standard operating procedures and IACUC requirements
- Demonstrated leadership skills
- Experience with client interactions and business development
- Proficiency in Microsoft Excel, Word, PowerPoint
- Proficiency with standard laboratory calculations
Benefits
- 401(k) Matching
- Vision Insurance
- Medical & Dental Insurance
- FSA
- Short Term Disability
- Long Term Disability
- Life Insurance
- Paid Holidays
- PTO
- Profit-sharing
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.