PROJECT MANAGEMENT IN DRUG DEVELOPMENT

Prerequisites & course information

Requisites: Declared in MS Pharmaceutical Sciences, Capstone Certificate in Applied Drug Development, or Capstone Certificate in Psychoactive Pharmaceutical Investigation Course Designation: Grad 50% - Counts toward 50% graduate coursework requirement Repeatable for Credit: No Last Taught: Fall 2026 Learning Outcomes: 1. Explain the concepts, principles and language of PM and its impact and role in the pharmaceutical industry. Audience: Graduate 2. Describe the functions of a Project Manager in general and within the drug development process (pre-clinical and clinical phases). Audience: Graduate 3. Compare and contrast different frameworks and tools of PM to make informed decisions on tailoring the PM approach to suit the project needs. Audience: Graduate 4. Develop a project charter, statement-of-work, scope of work, work-breakdown structure, a resource-loaded timeline, and a project plan. Audience: Graduate 5. Apply the critical path method and earned-value analysis to track progress and forecast outcomes against a project’s plan baseline. Audience: Graduate 6. Weight proper corrective measures according to earned-value analysis forecast methods, to ensure a project’s outcomes and deliverables. Audience: Graduate 7. Implement risk identification, mitigation and management strategies during project planning (pre-mortem), life cycle, and project closeout (post-mortem). Audience: Graduate 8. Consolidate the PM concepts and principles studied during the course by developing a Project Plan as Final Project. Audience: Graduate Learning Outcomes: 1. Explain the concepts, principles and language of PM and its impact and role in the pharmaceutical industry. Audience: Graduate 2. Describe the functions of a Project Manager in general and within the drug development process (pre-clinical and clinical phases). Audience: Graduate 3. Compare and contrast different frameworks and tools of PM to make informed decisions on tailoring the PM approach to suit the project needs. Audience: Graduate 4. Develop a project charter, statement-of-work, scope of work, work-breakdown structure, a resource-loaded timeline, and a project plan. Audience: Graduate 5. Apply the critical path method and earned-value analysis to track progress and forecast outcomes against a project’s plan baseline. Audience: Graduate 6. Weight proper corrective measures according to earned-value analysis forecast methods, to ensure a project’s outcomes and deliverables. Audience: Graduate 7. Implement risk identification, mitigation and management strategies during project planning (pre-mortem), life cycle, and project closeout (post-mortem). Audience: Graduate 8. Consolidate the PM concepts and principles studied during the course by developing a Project Plan as Final Project. Audience: Graduate