When Two Heads are Better - Pharmaceutical Executive


When Two Heads are Better
R&D president isn't one job–it's two. And to get them both done, maybe it's time to create a new position: COO of R&D

Pharmaceutical Executive

Given the importance—and cross-functional nature—of this effort, responsibility for it should rest in the hands of a senior executive. As members of the management team assess portfolio and resource allocation, the COO will help ensure that their decisions are internally consistent and aligned with the organization's strategy and willingness to tolerate risk. The COO will also ensure that all compound/drug projects across the R&D continuum use appropriate project management techniques. To facilitate this, the combined portfolio-project-resource management organization should report to the COO.

Management of initiatives R&D organizations are always engaged in a gamut of improvement activities. The biggest challenge they face is choosing among the many potential initiatives they could pursue, and the second-biggest is ensuring that approved initiatives are appropriately staffed and deliver promised benefits. The COO can aid in meeting both of those challenges. A key advantage of centralizing oversight authority this way is that a COO can ensure that interdependencies between initiatives are identified and appropriately managed. To that end, he or she will need the support of a small but dedicated initiative project management organization.

Support functions There are two principal reasons why the support functions (finance, informatics, human resources, facilities, and purchasing) should all report to the COO. The first is to relieve the CSO of the responsibility of dealing with the plethora of issues that the support functions cover. The second is that the COO needs to enlist and leverage these functions in a coordinated manner to improve operational performance.

Getting the Job Done The COO's job is to continuously improve operational performance in a challenging environment, characterized by unpredictability, complexity, and multiple interdependencies. To that end, it is essential to ensure that the four design elements—structure, process, systems, and people—are aligned at all times.

Structure deals with the governance of the organization and the assignment of responsibility and authority to decision makers and decision-making bodies.

Processes pertains to definition, standardization, and documentation of activities and workflows, as well as the standardization of templates and forms—CRFs and data clarification forms, for example. Process must be linked to roles and responsibilities. Each process step and deliverable must be linked to a specific job role. Aligning these elements is not a small task, but unless all four elements are aligned and mutually reinforced, work will not be done effectively and efficiently, and the changes will not stick.

Companies, both within and outside of pharma, are frequently unsuccessful in their efforts to redesign processes and implement systems. The cause generally is a failure to align all the elements in a timely manner. The sub-optimal performance of many project-management organizations is a case in point. While the stated expectation is that project managers will manage projects, frequently, the organization gives them neither the appropriate tools nor the authority to succeed. The fact that both the support functions and the combined portfolio-project-resource management organization will report to the COO will facilitate alignment.

Systems refers to tools that are appropriate, efficient, and configured to fully support the organization's processes. It also includes the capture and retrieval of information needed for decision-making, as well as performance metrics for tracking process performance and identifying improvement opportunities.

People Organizations interested in appointing one or multiple COOs will face the challenge of finding suitable candidates. The question of which qualifications and background are appropriate will generate significant debate and anxiety. Should the COO be a PhD, an MD, or an MBA? A company insider or an outsider? From within pharma or from some other industry? There is, of course, no single right answer, but there are some useful guideposts.

First, the COO needn't be a bench scientist or clinician, but must understand that simplistic, linear approaches that ignore the complexity, unpredictability and many interdependencies of R&D will fail. Second, a COO must have broad experience with process, systems, people and organizational structure issues, possibly including experience from outside the pharmaceutical industry. Finally, the candidate must have a burning desire to systematically improve performance, and the ability to enlist the support of others.


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