Direct the development, implementation and maintenance of Controlled Drug Substance (CDS) Program activities and overall site quality assurance systems. Apply leadership, knowledge and understanding of the obligations imposed upon all DEA registrants to compliment the basic requirements of FDA Current Good Manufacturing Practices (CMGPs).
Designs, plans, and implements clinical research projects. Participates in and coordinates the protocol and final clinical study report writing efforts. Conducts pre-study, initiation, and interim clinical study monitoring visits. Coordinates activities of clinical site to ensure compliance with protocol and overall clinical objectives.
Area of Interest: Research & Development
Job Type: Full-Time
Overall responsibility for managing pharmacology and experimental biology studies that provide pharmacodynamics component of early pre-clinical research activities either in house or in an outsourced environment as deemed necessary. Work closely with Global R&D teams to develop protocols and carry out execution of the pharmacodynamic (PD) studies.
"When we design a new drug candidate, we bring together our knowledge of a drug with our understanding of medicinal polymer chemistry and the body's mechanisms. This allows us to turn a sub-optimal drug into a new chemical entity with the potential to be more efficacious and have more desirable characteristics."
Timothy A. Riley, Ph.D. Senior Vice President, Global Research