Drug development is unpredictable The course of drug development is unpredictable and therefore it is critical to have realistic expectations for any given project. There are inherent difficulties in running a drug development successfully and the larger the project the more numerous potential problems can be. Accounting for the factors that can stand in the way of a project’s success and being able to take an objective view of the strategies required is a demanding, but necessary task.
Regardless of the amount that a pharmaceutical company decides to invest in its new drug pipeline, there is no chance of success unless a project is effectively managed. At present the pharmaceutical industry is under pressure to improve its productivity, as the number of new products reaching the market has been on the decline for a number of years. The productivity decline has led to many observers believing that the industry requires a new approach to the way in which it runs its projects.
It is these circumstances that have led to the rise of project managers in the pharmaceutical industry. Project managers are able to apply past experience to ongoing projects in order to solve problems in a practical manner whilst also being able to develop new approaches to resolve project-specific issues. Although it is impossible to predict every factor that will affect a project, by being proactive the major issues can be identified. Furthermore, any preconceptions can be challenged and alternative scenarios can be devised.
Focus on Pharmaceutical licensing
Alliances and collaborations are playing a greater role in drug development. Companies are finding that by licensing in compounds they are able to supplement their pipelines. In 2013 and 2014, over a quarter of the sales of the top 50 pharmaceutical companies were derived from in-licensed drugs and also huge royalties companies received from out license molecules. This approach allows the parties to benefit from the commercial and technical strengths of the other organization and the sharing of risk. Yet once again, careful management of a project is required if it is to have any chance of success. Poor project management could negate all the advantages that have been gained through potential collaboration.
Lets look into a pharmaceutical company what are the jobs project manager do or what companies expect project manager to do –
- Drives project planning, including assembling a written plan, tracking progress of execution towards targets, and performing risk analysis that anticipates potential problems and proactively develops back-up plans
- Partners with leads across functions (Development, Clinical, Regulatory, etc) to provide support and to achieve key milestones within the time, cost and quality parameters
- Ensures all projects are reviewed and approved according to Baxalta guidelines and standards, and ensures team understanding of SOPs and procedures
- Focuses executive time on most critical issues
- Resolves cross-functional barriers, delays, misalignments and misunderstandings
- Creates and syndicates communication on progress across project team, Baxalta-wide, and to external partners
- Identifies risks and make select interventions to meet objectives
- Responsible for integrating Process Development activities by developing and maintaining project schedules
- The Project Manager will partner with Process Development functional leads to identify key deliverable and will ensure cross functional alignment and accountability.
- Working with the Global Operations Team and technical leaders in Process Development to create project schedules
- Ensure participation in functional and cross-functional management reviews
- Establish and manage collaboration and team sites
- Track delivery and create repositories for all projects
- Partner with Business Analysis and Performance to report product metrics
- Facilitate and incorporate lessons learned, best practices, etc
- Support Business Process improvements
- Project reporting including appropriate risk analysis