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In the race to be first across the finish line for the Covid-19 vaccine project managers have a role

Boom or Bust? What is the key to the survival of biotechnology and pharma companies? Successful commercialization of its products. More often Project Managers and Project Management is becoming an important part of the strategy. How can scientists help bring best practices to their projects?

Biotechnology and pharma companies face constant challenges in the course of developing new drugs, vaccines or other products. Remember that it normally takes 10 years and $2 Billion to bring one product to market. Typically, most drug development processes experience planning problems, development delays, unforeseen challenges, cost overruns, and more. These limitations can be due to poor project handling by managers who have little or no formal training in dealing with the market, regulatory and development complexities of today’s projects.

The problem is particularly common in many biotechnology companies, where former academic scientists are often transplanted into management roles with little or no experience on the business side of science. It’s should be no surprise, then, that project management theories and activities are making major inroads into these industries, and project managers are becoming the most sought-after professionals and problem solvers. "There is a real gap for project managers in the marketplace, and it is expected that there will be a huge demand for project managers in the larger pharmaceutical and biotechnology industries in the near future," says Kathryn Pottruff, president of Micro Education Group Inc., a company specializing in strategic planning, project management, and consulting.

What Is Project Management?

Why should one look for project management skills? Why wouldn’t general managers and scientific teams carry out the same work? There is a difference in how projects and project management are perceived. Business management includes the overall operation and running of the company. It includes participation in multiple projects, including strategic planning, marketing, sales management, manufacturing, human resources, and financial planning.

Contrast with that a project. Projects are temporary, one-off activities organized to achieve a set objective or goal, with teams assigned for the duration of the project and strict attention paid to scheduling and budget. Project managers affect many different areas and are hired to develop marketing programs, launch drugs, run annual sales meetings, and manage clinical trials.

According to PMI: Project management in pharmaceutical companies confines itself to one project and focuses on the following:

· Setting project goals

· Putting strategic plans into practice

· Increasing productivity and efficiency of staff

· Establishing measures of success

· Quantifying value commensurate with cost

· Optimizing the use of organizational resources

· Incorporating quality principles

· Overcoming technical challenges

· Standardizing routine tasks--for example, formulating standard operating procedures and reducing the number of tasks that could potentially be forgotten

· Ensuring that available resources are used in the most effective and efficient manner

· Planning and executing for clinical evaluation

· Managing communications

· Providing senior management insight into "what is happening" and "where things are going" within their organization

· Reducing overheads

· Successfully scaling up the drug from discovery to market introduction

· Ensuring fast time to market.

So, where do scientists fit?

With scientific principles, every researcher brings some project management skills to the business. These are often skills learned along the way while grappling with a series of failed experiments, manuscripts and progress report deadlines, not to mention grant writing. Also learned are the interpersonal skills acquired when dealing with uncooperative colleagues and technical staff. If you have technical proficiency in your area of expertise; a bachelor's, master's, or doctoral degree in science; and organizational and people skills, then you are off to a good start and project management could indeed be the field for you.

In general, project managers need to have very strong people skills, negotiating skills, and the ability to resolve conflict and communicate effectively--skills not necessarily emphasized for scientists.

What Does A Project Manager (PM) Do Anyway?

The short answer - it depends on the business structure and size.

Small pharma companies tend to operate where each employee has one clear superior. Staff members are grouped by area of expertise, such as manufacturing, scientists, assay development, pre-clinical, etc. Usually, each department in a functional organization will do its project work independent of other departments. In this case a PM’s role is more of a coordinator or expediter than that of a real project manager.

The majority of the mid to large size pharma and biotech operate as either a strong matrix organization where PM’s have considerable authority which includes budgets and often have full-time project staff. While a balanced matrix organization recognizes the need for a project manager, it does not provide the project manager with the full authority over the project and project funding is still controlled by the functional areas.

Often in medium to large biotech and pharma organizations, development project managers take over the project leadership from discovery & research leaders at a predetermined point before the start of the pre-clinical stage and continue throughout all clinical development phases. There are many different roles within these organizations.

Project Coordinator or Project Planner (PC, PP): Project coordinators work to assist project managers teams with the coordination of resources, equipment, meetings, and information. They organize projects with the goal of getting them completed on time and within budget. They contribute to the management of cross-functional projects, especially to their planning (schedule, resources, budget) and execution. That role requires excellent planning, analytical and problem-solving skills.

Project Manager (PM): Project managers play the lead role in planning, executing, monitoring, controlling and closing projects. They are accountable for the entire project scope, project team, resources, and the success or failure of the project. They actively lead and motivate their team providing the global cross-functional team with drug development expertise as well as coaching and mentoring project team members. PM’s also execute using best practices to improve products, processes, and services.

Project Leader (PL) is the most senior position. They are responsible to lead the project work as the name suggests. They engage throughout the project life to lead the project team. They maintain the team dynamics. They never fail to show their leadership skills during a project, and they keep the team focus intact. They have team management and conflict resolution skills. In some of the organizations, where the functions take the projects, the functional heads delegate an individual to lead the project as a project leader. These project leaders work on ad – hoc basis on the projects.

Often each organization, large or small, will have it’s own unique set of roles that move it’s R&D and commercialization forward. Two major and distinct project management areas are in development and clinical operations. Industry learning curve led to increased appreciation of the project management discipline. Thus, there is a growing interest in incorporating the project manager positions in remaining pharma functions or departments such as regulatory, CMC (TechOps), pharmacology and others, adding further complexity to the comprehension of PM roles in our industry.

With projects taking substantial resources and time, it’s critical to have the right team assembled!

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