Per definition of PMI (Project Management Institute), project managers across different industries are assigned by the performing organization to achieve the project objectives. This is a challenging, high-profile role with significant responsibility and shifting priorities. It requires flexibility, good judgment, strong leadership and negotiating skills, and a solid knowledge of project management practices. A project manager must be able to understand project detail but manage from the overall project perspective. As the person responsible for the success of the project, a project manager is in charge of all aspects of the project including, but not limited to:
○ Developing the project management plan and all related component,
○ Keeping the project on track regarding schedule and budget,
○ Identifying, monitoring, and responding to risk, and
○ Providing accurate and timely reporting of project metrics.
The project manager is the lead person responsible for communicating with all stakeholders.
That being said, the pharmaceutical industry seems to follow only some of the facets of PMBOK and have a variety of different roles within project management function which may be confusing even to pharma veterans. Many job recruiters can see the difference either. Since have I worked in various PM roles, it may be just easier for me to guide the readers of this article through the meanders of development project management in pharma.
The scope of the pharmaceutical PM roles, their authority and accountability varies and depends on the organization structure and size. Small biopharma companies tend to operate as a function or weak matrix organizations, where each employee has one clear superior. Staff members are grouped by specialty, such as manufacturing, scientists, engineering, pre-clinical, etc. Specialties may be further subdivided into functional organizations. Usually, each department in a functional organization will do its project work independent of other departments. Project manager’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 strong matrix organizations, thus project managers have considerable authority, controls the budgets and has full-time project administrative staff (project coordinators or project planners). While the 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 that is still controlled by the functions.
Within the development, there are at least two major project management areas: one is within the development function, the other in clinical operations. The scope of responsibilities of those PMs is very dissimilar, which I will explain further. Also, many different departments in pharma recognize the importance of the project management discipline and create PM roles within functions (e.g. regulatory, CMC, pharmacology, and others). I am not going to talk about those roles, but it is worth to mention that this is a growing and positive trend in our industry.
In most medium to large biopharma 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. In general, project management role is to ensure execution of the project strategy by actively managing indication/molecule specific topics at the project teams. Companies have either all of the below-mentioned roles or just some of them. The most senior level PMs may manage not only operation but also strategies. Experienced PMs may advance to lead programs. Below are few categories of positions within project management one can encounter in biopharma:
- Project Coordinator or Project Planner (PC, PP) are most junior and entry level roles within project management function. They work in conjunction with project managers and leaders, 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) actively leads and motivate teams to reach project objectives. Provide the global cross-functional project team with project management and drug development expertise and coach and mentor project team members. Recommends best practices to improve products, processes, and services. Is accountable for project execution, risk planning, and proper reporting. That role requires a graduate degree and previous expertise in PM function (3-5 years, e.g. as project coordinator).
- Project Leader (PL) is the most senior position, as the individual carries responsibility for both strategy and operations of the single project. Often leads projects with significant risk and complexity. PL position requires a graduate degree and extensive professional experience (approximately 12-15 years).
- Program Leader (PGL), is not a PM role but requires similar strong PM background. Many PMs progress into PGL roles during their careers. Program leader is accountable for the strategy and execution of the large program (and all projects within), usually in pre-launch stage of lifecycle management. Leads a multidisciplinary team of functional experts securing global regulatory approvals, market access, and optimized commercial value of the program. Assures quality and full compliance with regulatory requirements, while operating within budget and in a competitive and timely manner. Delivers cross-functional development and life cycle plans for the approved development option and obtain implementation plan approval (time, cost, quality) at the governance body. That role is most senior and often requires a graduate advanced degree (MSc, Ph.D., MD) and extensive professional experience (approximately 15+ years).
Another type of biopharma project management role is the Clinical Project Manager. That role within clinical operation function is accountable for the management of clinical trials (also referenced as ‘projects’). CPM seats usually in development team led by development PM. Indeed, when the drug hits the clinical development stage, there is an overlap between clinical operations deliverables (managed by CPM) and project deliverables (managed by PM). However, well-described roles and responsibilities for both roles should resolve some of the issues in day to day management of the various sub-teams.
Clinical Operation department in large pharma offers a variety of different positions: clinical trial coordinators (admins), study managers (accountable for single trial), program managers (responsible for multiple trails within a program). The logic of the roles follows what was previously described for development PM roles.
Pharmaceutical project management is an exciting and demanding career option with a broad range of entry and senior level positions, depending on the size and structure of a given organization. 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.
References: A Guide to the Project Management Body of Knowledge (PMBOK® Guide)–Fifth Edition.