Main description:

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.

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