Study Director, Developmental and Reproductive Toxicology (DART)

Frontage Laboratories•Chicago, IL

6d•$95,000 - $130,000•Onsite

About The Position

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! 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.

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.
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.

Nice To Haves

DABT certification preferred but not required.

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.