Project Management for Drug Developers

Project managers in drug development are the driving force behind the coordination of efforts. This book provides a practical reference for project managers in the pharmaceutical and biotech drug development industry, with the goal of assisting in creating an efficient and effective team structure and environment. The text details the role of project managers at each stage of drug development, the key interfaces that the PM will need to work closely with, and essential tools of the trade including frequently used techniques and methodologies. This book is useful for both entry-level and advanced-level PMs, as well as non-project managers from other functions. Features Includes authors' recent experience with improved tactics and technologies/software at various stages of drug development. Provides the most up-to-date and best practices, techniques, and methodologies in project management. Details the role of the PM at each stage of drug development, including working with the key interfaces throughout the process. Diverse audience including nonproject managers in clinical development, clinical operations, regulatory affairs, medical affairs, clinical pharmacology, and biostatistics. Provides templates and timelines for critical paths from development to commercialization and has potential as a textbook on relevant courses.

Part 1: The Role of PM in Drug Development Overview of Drug Development (Hourik Miller) Project Management’s Place in Drug Development and the Various PM Roles in Biopharma (Joseph P. Stalder) Project Teams (Joseph P. Stalder) The Project Management Office (Norbert Leinfellner) Project Portfolio Management (Mark Christopulos) Part 2: Contemporary Topics in Drug Development Managing Projects with an Agile Mindset (Kamil) Managing International Projects (Henri Criseo) Managing Combination Drug-Device Projects (Rhonda Peck) How Technology Can Assist Project Managers Now and in the Future (Dave Penndorf) Assessing, Selecting, and Implementing a Project Management Information System (Dave Penndorf) Creating an Asset Development Plan (Joseph P. Stalder) Creating a Clinical Development Plan (Joseph P. Stalder) Creating a Market Application Submission (Joseph P. Stalder) Part 3: GRIDALL: A Comprehensive Framework for Managing Projects Introduction to GRIDALL (Joseph P. Stalder) Goals (Joseph P. Stalder) Risks (Joseph P. Stalder) Issues (Joseph P. Stalder) Decisions (Joseph P. Stalder) Actions (Joseph P. Stalder) Lessons Learned (Joseph P. Stalder)

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.