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Examining the Implications of Scientific and Operational Alignment In Clinical Pharmaceutical Environments

Pharmaceutical companies wishing to develop or recruit senior clinical management with both scientific/medical and operations experience will find that hard to achieve because of the separation of skill sets within their organizations and the external talent market.

Research exploring the implications of scientific/medical and operational alignment within the pharmaceutical environment by The Stevenson Group, a leading global pharmaceutical and life sciences specialist executive search firm, suggests a significant deficit in the cross-functional training some companies now offer as they crystallize their vision for filling future requirements for key clinical positions.

Crux of the challenge

Most pharmaceutical companies have not succeeded in fusing the operations - including protocol design, study leadership and clinical trials management - and clinical science/medical sides of their businesses.

Our market research interviews with leaders in the pharmaceutical community confirm the view that while there is currently strong matrix management and committee involvement between leaders on the scientific and operations sides of clinical trials and development, the blending of knowledge and leadership skills is not being aggressively planned for and pursued.

The very limited number of career crossovers by leaders from one side of the clinical ladder to the other remains a significant challenge for organizations intent on marrying operational know-how with scientific leadership.

Organizations that desire to bring science and operations closer together are finding that task difficult, because the lack of designed crossovers opportunities from Operations into Development, and vice versa.

Often, the interaction of the operational and clinical science teams assigned to a pharmaceutical compound, brand or drug campaign depends on the size of the program and the priority and resources it is given. The pressures of time, goal achievement and resource limitations impact training opportunities.

The crossover challenge

In most pharmaceutical companies today, scientific/medical and operational cross training occurs through matrix committee involvement. Operations typically write non-medical portions of protocols, oversee clinical trials and data collection, and in many cases, even bio-statistics is a separate unit.

Clinical trial leaders should have the scientific/medical as well as operations experience, knowledge and agility, if the organization values the human capital advantage the combination of those experience sets may create.

Many Global Medical/Brand Directors have both scientific and operational experience, but fewer executives with titles such as Senior Clinical Trial Heads, Vice President of Project Management, or Director of Clinical Development, can draw from the same wealth and diversity of career and management experience.

Our market research finds that MD's now heavily populate both the Clinical Development ladder and the leadership pipeline for such leadership positions. Meanwhile, the Operations ladder and existing senior-management "bench" consists almost entirely of business leaders who've earned either a PhD or PharmD.

In many companies, the trend is to outsource the operations function to CROs. In house, the trend appears to keep operations and clinical development aligned but separate.

The physician leader who spearheads a brand' or compound's global clinical development efforts, typically has a Clinical Operations liaison assigned to his or her team and they interact through a matrix organization. Clinical Operations and Clinical Development are separate in most organizations, with pre-clinical efforts an entirely separate entity as well.

Occasionally, there are MD's or PhD's who may start on the Operations side and eventually transfer to the scientific team, but most MD's enter the organization at the Associate Director level on the clinical side and progress on that side of the ladder.

Physicians in many companies, do not look at Operations as a logical career move, nor do operations executives typically aspire to a transition into Development. Those dynamics only underscore the challenge of moving clinical operations and clinical science closer together.

Assessing the opportunity

So will pharmaceutical leaders on both the scientific and operational sides of leading companies and in the external marketplace respond positively to career opportunities on the other side? And will pharmaceutical companies ever realize the full impact of this potentially transformational partnership between science/medicine and operations?

Based on our market research, we believe that PhD's and PharmD's remain the best choices for Operations leadership. We have also found that matrix committee involvement exposes operations and science executives to some cross training.

The consensus among the business leaders we've interviewed suggests that today's pharmaceutical management teams must open up more meaningful cross training career opportunities to realize the potential of pulling science and operations closer together. Effective titling is certainly a key point to consider, as is compensation and setting realistic objectives.

The physician in charge of the science must recognize and value the contributions that operations executives can bring. Operations teams must also see how physician leaders can add significant insight into the operations that support the campaign behind a brand, compound or other pharmaceutical agent.

"When you get to a certain level and reflect on management responsibilities and leadership, if the cross-training and exposure has been satisfactory, the physician can have the operations team report to them," says Stephen M. Steinman, President and CEO of The Stevenson Group.

"Such cross training can resolve the problem that currently exists and bring a larger number of potential leaders into the industry," Steinman says. "It also promises to eliminate the glass ceiling and allow people to cross over between the science and operations."