| Description |
1 online resource (313 p.) |
| Series |
Drugs and the Pharmaceutical Sciences Ser |
|
Drugs and the Pharmaceutical Sciences Ser
|
| Contents |
Cover -- Half Title -- Series Page -- Title Page -- Copyright Page -- Table of Contents -- Foreword -- Preface -- Glossary of Terms and Abbreviations -- Editor -- Contributors -- PART 1 The Role of PM in Drug Development -- Chapter 1 Overview of Drug Development -- 1.1 Introduction -- 1.2 Preclinical Development -- 1.2.1 Pharmacodynamics (PD) -- 1.2.2 Pharmacokinetics (PK) -- 1.2.3 Toxicology -- 1.3 Early Clinical Development -- 1.3.1 Phase 1 -- 1.3.2 Phase 2 -- 1.4 Late Clinical Development -- 1.4.1 Phase 3 -- 1.5 Innovative Clinical Development Strategies -- 1.5.1 Seamless Trials |
|
1.5.2 Master Protocols -- 1.5.3 Regulatory Flexibility -- 1.6 Registration -- 1.7 Lifecycle Management -- 1.8 Summary -- Chapter 2 Project Management's Place in Drug Development and the Various Project Management Roles in Biopharma -- 2.1 Introduction -- 2.2 What Is Project Management and What Does a Project Manager Do? -- 2.3 Evolution of Project Management in Biopharma -- 2.4 What Do Project Managers Do in Biopharma? -- 2.4.1 Research Project Manager -- 2.4.2 Development Project Manager -- 2.4.3 Commercial Project Manager -- 2.4.4 CMC Project Manager -- 2.4.5 Regulatory Project Manager |
|
2.4.6 Emerging Roles for Project Managers in Drug Development -- 2.5 Who Becomes a Project Manager in Biopharma? -- 2.6 What Makes for a Successful Development Project Manager? -- 2.6.1 Collaboration of Multiple Disciplines -- 2.6.2 Coordination of Business Processes -- 2.6.3 Communication across Multiple Stakeholders -- 2.6.4 Management of Risks and Issues in a Cross-Functional Context -- 2.7 Summary -- Chapter 3 Project Teams -- 3.1 Introduction -- 3.2 Project Team Models -- 3.2.1 Top-Down Hierarchy -- 3.2.2 Hub and Spoke -- 3.2.3 Latticed Network |
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3.3 Components of a Hub-and-Spoke Project Team -- 3.3.1 Core Team -- 3.3.2 Sub-Team -- 3.3.3 Task Forces and Working Groups -- 3.3.4 Joint Teams -- 3.3.5 Tying It All Together with a Project Team Charter -- 3.4 Roles within a Project Team -- 3.4.1 Executive Sponsor -- 3.4.2 Project Leader -- 3.4.3 Project Manager -- 3.4.4 Sub-Team Lead -- 3.4.5 Functional Area Representative -- 3.4.6 Functional Area Head -- 3.4.7 Technical Expert -- 3.5 Functional Representation within a Project Team -- 3.5.1 Clinical Operations -- 3.5.2 Clinical Pharmacology -- 3.5.3 Clinical Science -- 3.5.4 Commercial |
|
3.5.5 Medical Affairs -- 3.5.6 Research/Nonclinical Science -- 3.5.7 Pharmaceutical Science/CMC/Technical Operations -- 3.5.8 Regulatory Affairs -- 3.5.9 Other Key Interfaces with the Project Team -- 3.6 Team Culture, Dynamics, and Leadership -- 3.6.1 Characteristics of a High-Performance Team -- 3.6.2 Meeting Operating Norms -- 3.6.3 Managing through Disruption -- 3.6.3.1 Organizational Shifts in Priority -- 3.6.3.2 Departmental Reorganizations -- 3.6.3.3 Mergers & Acquisitions -- 3.6.3.4 Team Member Turnover or Nonperforming Members |
| 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 |
| Notes |
Description based upon print version of record |
|
3.6.3.5 Abrupt Handover of Responsibility to a New Project Manager |
| Form |
Electronic book
|
| ISBN |
9781000828436 |
|
1000828433 |
|
