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
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
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.