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This book provides a practical reference for project managers in the pharmaceutical and biotech drug development industry. The text details the role of project managers in drug development, the key interfaces throughout drug development, and tools of the trade.
List of contents
Part 1: The Role of PM in Drug Development
I. Overview of Drug Development
II. Project Management’s Place in Drug Development and the Various PM Roles in Biopharma
III. Project Teams
IV. The Project Management Office
V. Project Portfolio Management
Part 2: Contemporary Topics in Drug Development
I. Managing Projects with an Agile Mindset
II. Managing International Projects
III. Managing Combination Drug-Device Projects
IV. How Technology Can Assist Project Managers Now and in the Future
V. Assessing, Selecting, and Implementing a Project Management Information System
VI. Creating an Asset Development Plan
VII. Creating a Clinical Development Plan
VIII. Creating a Market Application Submission
Part 3: GRIDALL: A Comprehensive Framework for Managing Projects
I. Introduction to GRIDALL
II. Goals
III. Risks
IV. Issues
V. Decisions
VI. Actions
VII. Lessons Learned
About the author
Dr. Joseph P. Stalder
Joe Stalder, Pharm.D., PMP, is a Senior Director of Project Management at Mirati Therapeutics in San Diego, USA. He received his Bachelor's degree in Pharmacology from the University of California, Santa Barbara, and his Doctor of Pharmacy program at the University of California, San Diego. After receiving his PharmD, he completed a post-doctoral fellowship at Forest Laboratories in New York/ New Jersey, during which he also served as an adjunct professor at St. John's University in Queens, NY. Joe has more than 10 years of project management experience in pharmaceutical development in both large and small companies. His experiences include PM department head, PMO head, and PM Lead on several late-stage development assets in oncology, infectious disease, cardiology, metabolism, and pulmonology.
Summary
This book provides a practical reference for project managers in the pharmaceutical and biotech drug development industry. The text details the role of project managers in drug development, the key interfaces throughout drug development, and tools of the trade.
