Study Director

Reaction Biology is a contract research organization (CRO) that was founded in 2001. We provide contract research services to over 1500 clients worldwide through our labs in Malvern and Hershey, Pennsylvania and Freiburg and Heidelberg, Germany. Our clients are seeking answers in their request to discover effective treatments for patients. Finding these answers is our mission as a CRO. Our method is to accelerate the drug discovery process with the widest possible range of assays and services but also to maintain an integrated view of the journey to a lead drug candidate. We strive to provide excellent data, delivered in a timely, collaborative manner by outstanding scientists. Come join our team!

Position Summary:

The Study Director is a mid-senior level onsite position based out of Hershey, Pennsylvania and is responsible for managing all phases of in vitro and in vivo studies while embodying the overall company culture. The Study Director will have proven experience interfacing with various internal and external stakeholders to drive all phases of project management in a fast-paced setting, ensuring sound execution of multiple parallel projects that are completed on time and within scope and budget.

Main Responsibilities:

• Responsible for coordinating study conduct tasks from study initiation to study archiving, including the interpretation, analysis, documentation, and reporting of results.

• Assists in preparation of clear, well-organized, scientifically sound reports.

• Works with our internal team to evaluate proposals, evaluate feasibility, and provide recommendations to clients.

• Functions as the principal point of contact for activities related to assigned studies.

• Serves as the primary contact for the client, and keeps the client informed of schedule and any unforeseen events or issues.

• Leads client discussions to provide effective study design and protocol development.

• Creates study-related documents and manages electronic data entry.

• Ensures that the protocol and any amendments are approved and are in compliance with the appropriate SOPs, applicable quality system regulations (i.e. GLPs) and regulatory agency guidelines.

• Establishes and ensures schedule, budget and quality commitments are met for the client.

• Interacts as needed with clients, auditors, inspectors, subcontractors, and consultants.

• Knows and understands the Animal Welfare Requirements and prepares protocol submissions for IACUC review.

• Serves as the Study Director for GLP and non-GLP preclinical studies and assures that all applicable GLP regulations are followed. Serves as Principal Investigator, when applicable.

• Assures that all data including unanticipated responses are accurately recorded, verified, and organized.

• May need to participate in hands-on technical execution of studies.

Key Qualifications:

• PhD with a minimum of three years' of related oncology/immunology industry/CRO experience.

• Knowledge of Good Laboratory Practices for Nonclinical Laboratory Studies (21 CFR Part 58) is highly desirable.

• Knowledge and experience with quality systems

• Demonstrated knowledge of scientific data analysis and technical writing