Study Director

Job Description

Job Description

Reaction Biology is a global contract research organization (CRO) with laboratory facilities in Malvern, PA, Hershey, PA, Freiburg, Germany and Heidelberg, Germany. We provide drug discovery research and development services to biopharmaceutical customers worldwide. Our capabilities and services include protein & peptide production, biochemical and biophysical assays, high-throughput screening, an extensive array of cell-based and pharmacological assays modeling various diseases, exploratory toxicology, biomarker discovery, and pharmaceutical batch release testing.

Since its inception in 2001, Reaction Biology has grown to become a global leader in drug research and development, assisting in the discovery of life-saving therapeutics for diseases such as cancer and neurodegeneration. Reaction Biology has assisted in the advancement of many of its customers' drug candidates through the preclinical pipeline stages into later clinical phases. Reaction has one of the world's largest panels of kinase assays, with over 780 kinases, and performs more than 5,000 client projects annually with over 2,000 validated assays and growing.

Position Summary:

The Study Director 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, technical writing, organizational and communication skills.
• Project management, verbal communication, multi-tasking and problem-solving skills.
• Self-starter with a strong sense of ownership of work
• Good organizational and time management skills
• Flexibility to accommodate rapidly changing priorities and deadlines.

Reaction Biology Corporation is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived person's race (including hairstyle/texture), color, national origin, age, religion, disability status, sex, sexual orientation, gender identity or expression, genetic information or marital status, or any other characteristic protected by applicable federal, state or local laws. Reaction Biology is an E-Verify employer.