Muutke küpsiste eelistusi

Project Management for Drug Developers [Kõva köide]

Edited by (Senior Director, Mirati Therapeutics, USA)
  • Formaat: Hardback, 288 pages, kõrgus x laius: 234x156 mm, kaal: 640 g, 60 Line drawings, color; 3 Halftones, color; 63 Illustrations, color
  • Sari: Drugs and the Pharmaceutical Sciences
  • Ilmumisaeg: 29-Dec-2022
  • Kirjastus: CRC Press
  • ISBN-10: 103212668X
  • ISBN-13: 9781032126685
Teised raamatud teemal:
  • Formaat: Hardback, 288 pages, kõrgus x laius: 234x156 mm, kaal: 640 g, 60 Line drawings, color; 3 Halftones, color; 63 Illustrations, color
  • Sari: Drugs and the Pharmaceutical Sciences
  • Ilmumisaeg: 29-Dec-2022
  • Kirjastus: CRC Press
  • ISBN-10: 103212668X
  • ISBN-13: 9781032126685
Teised raamatud teemal:
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.

Arvustused

Project Management for Drug Developers, First Edition" edited by Joseph P. Stalder is a must-have for seasoned project, program, and portfolio leaders in the biopharma industry, for recent graduates embarking on careers in drug development project management, and professionals transitioning into project management roles within the biopharma sector. This comprehensive resource provides insights into the essential role of project management, explores contemporary themes in drug development, and presents a robust framework for project management known as GRIDALL.

Having utilized and endorsed this book while mentoring junior project managers, I can attest to its clarity in outlining the typical drug development process, emphasizing the importance of project management methodologies at each phase, and defining the functions and accountabilities of project teams. Noteworthy chapters cover topics such as the project management office, project portfolio management, agile project management, international project management, and the utilization of technology and project management information systems. These chapters establish a solid groundwork for organizations progressing towards greater operational complexity and maturity, broadening their asset development pipeline, or engaging in global initiatives.

Furthermore, the authors provide practical, real-world advice on crafting asset development plans, clinical development plans, market application submissions, and a comprehensive project management framework. This guidance proves invaluable for swiftly formulating plans or assuming responsibilities for new projects.

I wholeheartedly endorse this book and am confident that, like me, you will frequently turn to its pages for guidance and insight (as evidenced by my well-thumbed copy).

Stephen Smith

Senior Program Director

Corcept Therapeutics

Foreword ix
Preface xi
Glossary of Terms and Abbreviations xiii
Editor xxi
Contributors xxiii
PART 1 The Role of PM in Drug Development
Chapter 1 Overview of Drug Development
3(14)
Hourik Miller
Chapter 2 Project Management's Place in Drug Development and the Various Project Management Roles in Biopharma
17(16)
Joseph P. Stalder
Chapter 3 Project Teams
33(22)
Joseph P. Stalder
Chapter 4 The Project Management Office
55(16)
Norbert Leinfellner
Chapter 5 Project Portfolio Management
71(20)
Mark Christopulos
PART 2 Contemporary Topics in Drug Development
Chapter 6 Agile Project Management and Its Application to Drug Development
91(18)
Kamil Mroz
Chapter 7 Managing International Projects
109(14)
Henri Criseo
Chapter 8 Managing Combination Drug-Device Projects
123(10)
Rhonda Peck
Chapter 9 How Technology Can Assist Project Managers Now and in the Future
133(20)
Dave Penndorf
Chapter 10 Assessing, Selecting, and Implementing a Project Management Information System
153(24)
Dave Penndorf
Chapter 11 Creating an Asset Development Plan
177(8)
Joseph P. Stalder
Chapter 12 Creating a Clinical Development Plan
185(18)
Joseph P. Stalder
Chapter 13 Creating a Market Application Submission
203(12)
Joseph P. Stalder
PART 3 GRIDALL: A Comprehensive Framework for Managing Projects
Chapter 14 Introduction to GRIDALL
215(6)
Joseph P. Stalder
Chapter 15 Goals
221(12)
Joseph P. Stalder
Chapter 16 Risks
233(10)
Joseph P. Stalder
Chapter 17 Issues
243(6)
Joseph P. Stalder
Chapter 18 Decisions
249(10)
Joseph P. Stalder
Chapter 19 Actions
259(6)
Joseph P. Stalder
Chapter 20 Lessons Learned
265(6)
Joseph P. Stalder
Appendix I Team Performance Survey 271(2)
Appendix II List of Common Agile Practices 273(2)
Appendix III New PM Onboarding Checklist 275(4)
Appendix IV Transition Plan 279(2)
Appendix V Resource Management Definitions 281(2)
Appendix VI Generic Job Description for a Director-Level Development Project Manager 283(4)
Index 287
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.