Once upon a time, this was the way of things: Most projects happened in-house, or at least locally, and the activities they required weren't very complicated. In today's global business environment, however, the days of such simplicity are gone. Instead, now the “+1” person in the N + 1 equation (see the box at right) is the glue that holds complex, global activities together for a company. That person is the project manager.

Simply stated, project management (PM) is the management of people, activities, time, and money toward the successful completion of a stated goal. That sounds easy, and we do it all the time in our daily lives. But it is imperative in the complex world of biopharmaceuticals to have a single point person responsible for ensuring that all the pieces of a project come together efficiently, effectively, and on schedule.

Picture This: First, consider the management of people. Imagine you are team leader of a group responsible for delivering a phase 1 clinical trial antibody product. You're excited to be chosen as a team leader because it is an excellent chance to develop your career. Of course, it comes in addition to your regular technical responsibilities. You are also personally responsible for the expression, filtration, and purification of the antibody.

(Click to enlarge)

As team leader, you need to coordinate with various functional groups including analysts, formulators, and clinical manufacturing personnel — and even clinicians — to outline the activities that must be accomplished to get the product to the clinic. To that end, you create a flow chart like that in Figure 1. You meet with your team every week to discuss the status of the program, going through the chart step by step to ensure that everyone is working together to meet an impossible timeline. The work is hard, intense, and time-consuming, but progress is made. You have a cohesive team progressing at an acceptable pace.

THE CLASSIC VIEW

Q: How many technical personnel does it take to complete a project?

A:N + 1 (“We'll throw in as many as it takes to get the product out the door.”)

Q: How many project managers does it take to complete a project?

A: Zero (“They don't do anything really meaningful, anyway.”)

Figure 1: (Click to enlarge)

Now the antibody is purified, and it's passed off to the analysts and formulators. They work with the clinical manufacturing group to scale up and make the full formulation batches. The finished product goes to release testing laboratories at the same time it goes to the clinical packaging group for labeling. Then the drug is found to be within specifications and can be released for shipping to the appropriate test sites for clinical trials — just as the f low chart says, and just in time.

But someone forgot to include shipping personnel in the project team so they would know that this particular antibody had to be kept cold. Neither were they told that the product couldn't be shipped on Fridays because no one would be at the clinic to receive it over the weekend and store it at the necessary 5 °C. So the precious drug was shipped at ambient summer temperatures and sat on a loading dock for nearly 48 hours. Oh no!

You get a call on Monday morning and find out that whole clinical program is now delayed by months because no one managed the shipping department. And this is the moment when you, as team leader, wish that you'd had a project manager on the case.

Doing Something Meaningful: Among other things, a project manager's role and responsibility is to ask the right questions of the project team to ensure all the appropriate steps are taken and the program is executed as expected. This person's role also includes outlining all pertinent operations, keeping track of how they interact with one another, and making sure all appropriate people are included and informed — and have approved — of the process. For example, the project manager would have apprised the shipping department of that hypothetical drug's logistical issues.

PM activities extend not only to the team responsible for tactical operations (e.g., scientists, manufacturing, and shipping personnel), but must also include management (strategic operations). Upper/executive managers typically establish a program definition in the first place. Their strategic vision needs to be translated and communicated to the tactical team so all involved are clear about expectations. It is a project manager's responsibility to take that vision and track it for the team to ensure that the members stay true to its intentions. A project manager can also help them prepare and present their strategy for the overall plans and mitigation of risks to upper management through well- crafted and well-placed questions. Finally, if something goes wrong — and it inevitably will — the project manager is often faced with tempering the expectations of upper management so that they understand what has happened and why.

In many companies, team leaders double as project managers. Sometimes this works, especially if those people are well versed in the entire chain of events from start to finish of a program, including events outside their own areas of expertise. Often, however, a team leader also has his or her own activities to address, which can consume a lot of time and effort beyond project management.

It can help a team tremendously to have one person who is fully and completely responsible for managing all activities and communications through meetings, minutes, and other interactions. An assigned project manager can also track the details of all resources — personnel and otherwise.