How can clinical development be fixed?

By Laurie Halloran

It's no surprise that like many other industries, the biopharma industry is experiencing growing pains in the new flat and economical world and is learning to run on increasingly tighter limits with little room for error.

During a recent retreat with senior management from the industry organized by our consulting group, there was a common thread to all concerns – finding and developing good people and the need for strong leadership are critical in sponsor companies. And yet biopharmaceutical companies of all sizes have been putting the development of their people by the wayside.

In such a difficult climate, management is concerned with reaching milestones, staying on budget, regulatory scrutiny, and their board and investors. However, when development, training and management of people is overlooked, overall work quality and ability to retain committed, highly qualified people deteriorates.

What are the causes?

Senior management's explanation for less-than-desirable organizational situations is "this will be temporary." The reality is that in an environment of constant change and firefighting, development and management of people is often too low on the list of priorities to ever be addressed. Unfortunately, by deferring the importance of developing and managing their people, companies are actually losing out on quality and efficiency, the very things they seek to improve within their organizations.

People inherently want to do good work, so what are the underlying issues that lead to problems between people and quality? It may be as simple as a person not understanding or knowing what to do in the job they have been hired to fill. This leads one to look at the recruitment, interviewing and training functions, which lay in the domain of HR. However, the success or failure of the company in clinical development rests squarely within these functions, and are often not a focus of the development organization's management team except as an afterthought.

Advancing employees internally without regard for developing them first is problematic. People in clinical research are often promoted based on their technical skills, but management of people and projects are difficult to mix: the projects take precedence and the people suffer. Technical experts turned managers and directors always gravitate toward what they know best-their technical expertise. Executive management often has little to no awareness of absence of managerial skills within their organizations until a lapse on the front line. That can often make the difference between success and failure.

What do we do now?

The three strategies most discussed in our retreat were recruitment and hiring of the right people, developing leadership and management skills at all levels of the organization and the importance of setting training, coaching, and mentoring as a priority.

The first step begins during the recruitment and interviewing process. It is as simple as selecting and hiring team members thoughtfully so that they bring skills and knowledge to a project that are appropriate and complementary to the larger group. This can only be accomplished through high quality, well-coordinated candidate selection and behavioral interviewing based on the competencies sought for the position. However, in many companies there is a significant disconnect within this process and there are often issues with who is identifying and selecting candidates in the first place.

Additionally, as the industry expands rapidly within regions with a dense clustering of biopharma companies, the competition for the best people becomes increasingly difficult and hiring executives often find themselves filling a void rather than finding the right person.  A hiring mistake consumes the bandwidth of existing management, and turns the focus in the wrong direction, away from the top performers. Today, top candidates at all levels within a clinical development organization have many choices and are increasingly critical of who they select as an employer. If good people are leaving, all levels of management within the company must ask themselves why.

The second most common reason employees leave is that executive or mid-level management doesn't "get it"-meaning the inexperience or naiveté of the management team (at any level above the individual's). If the executive team doesn't "get it", they cannot provide the support (money, time, etc.) needed to execute programs without constantly demanding proof that it is necessary.  This just leads to frustration by competent, highly qualified clinical pros and no amount of managing up by clinical development can instill the wisdom learned from having lived through the process.

People can be developed through both training and mentoring, but there must be commitment from executive management both in terms of time and cost. Training programs can be very valuable to an organization by advancing the knowledge and skills of team member with the expectation of improving the quality of their work, but they are only the beginning. Without the time to manage, the skills to lead, and the freedom to build in quality, training won't stick and people won't perform. If there is no internal capacity to build such programs, the executive team needs to find trusted advisors who can mentor and guide them through it.

Finally, management and leadership development is not instilled in a two-day class or a week-long offsite. It must be emulated and lived within the culture of the company-from the top down.

Conclusion

What would happen if we all took a step back and, for just a moment, stopped focusing on the race to the finish line of drug development, stopped worrying about costs, timelines and how to maximize efficiencies, and realized that the industry is losing sight of its people?

It would be devastating because the industry is its people. They want to see that their work contributes to the overall success of a company. In order to achieve this, they need to be given opportunities that utilize their skills and competencies, supplemented with the right tools to develop and management with good leadership skills to imitate. Success for the organization must be built from strong, ethical and wise leadership.

Laurie Halloran (lhalloran@hallorancg.com) is CEO & Managing Partner at Halloran Consulting Group and is recognized as an industry expert in improving the organizational effectiveness of clinical research programs with a specialty in gap analysis and strategic planning.