Study Director

Title : Study Director

Location : Chicago, IL (onsite)

Reporting to : Director of Toxicology

Full-time

Frontage Laboratories Inc. is an award winning, publicly listed (HKSE), full-service CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada and China, and growing over 30% YOY. 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.

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.
• Function as a key contributor for the planning, execution, management, and reporting of preclinical studies.
• Coordinate all phases of the study planning process with appropriate departments and Sponsor Representatives.
• Generate high-quality protocols, amendments, and reports.
• Review, interpret, integrate, and present data on assigned studies.
• Provide technical and scientific guidance to the research staff.
• Review reports for peers as needed.
• Attend scientific meetings, conferences, and training courses to enhance job and professional skills.

Education, Experience & Skills Required :

• Education: Bachelor’s degree (B.S./B.A.) or equivalent in a scientific related discipline. Master’s or Ph.D. in Toxicology, Developmental Biology, Pharmacology, Physiology, or related field strongly preferred.
• Must have expertise in toxicology with at least 2 to 5 years’ post-degree experience as a study director.
• Prior experience in a CRO environment is very desirable.
• In vivo laboratory and hands on experience required.
• 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.
• Ability to handle multiple projects, prioritize work and meet deadlines.
• 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 and Benefits :

Frontage Laboratories offers a competitive compensation and benefits package including health and dental insurance, a 401(k) plan, disability insurance, and life insurance.

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 .