In my (ahem) more than 25 years helping organizations navigate change, I have not met a more complex, cross-functional, regulated world than clinical drug development. During that time, my colleagues and I have come to recognize the tell-tale signs of growing and scaling pains in small to mid-size life science organizations. While there’s not a one-dose-fits-all solution for every malady, we’ve discovered a “cocktail” of sorts based on three remedies, which, when used together, provide dramatic relief.
It’s true that prevention is the best medicine, but growing pains are normal, perhaps inevitable. In Future State’s human-centered work, we’ve surveyed hundreds of employees who are in the throes of clinical drug development. Nearly 100% of the time, the challenges we encounter are consistent, impacting business outcomes and people outcomes. While I could write a post entirely on that topic, whether the pain is related to putting out fires or quality issues or hero fatigue, the remedies are the same.
Too often, companies rely on loosely held tribal knowledge or the oversight of already stretched key leaders to maintain order. To reduce compliance risk and fire drills, however, defining and understanding cross-functional processes is a must.
For a life science organization preparing for clinical trials, filings, and, ultimately, an authorized, marketed product, multiple sets of functional experts must engage in a highly orchestrated dance. And nothing is more effective in assuring all goes well than taking the time to define and visualize a few key processes.
Through a well-orchestrated, focused effort to define and visualize key cross-functional processes, you will gain:
Since process is so important, perhaps it’s not surprising that the process used to define and visualize process matters. Most critically, involve your key functional subject matter experts (SMEs) in this important work. A documented process is useless if no one knows about it, or, worse, if no one feels they had a say in developing it.
Anyone who has tried to drive change in late phase clinical development at a large pharma or biotech has wished for a cross-functional process owner. In small to midsize organizations, you can establish this role early. But what does a process owner do, and who makes a good process owner?
Clinical Operations Lead/Program Lead
Interestingly, many of the same characteristics apply for clinical operations leads or program leads. Optimistic and pragmatic are a unique combination, and you know it when you see it. My colleagues and I at Future State describe these crucial team members as orchestra conductors who solve problems while keeping all of the functions moving in concert. In both of these roles, leadership skills are more important than process knowledge and subject matter expertise. The challenges and opportunities that face these important leaders require constant change management, alignment, influence, and engagement skills.
Finally, it pays to invest energy early in establishing ground rules and solutions that enable the processes. By adopting a few agile methods and addressing the team’s basic need for information, cross-functional team members can get to the information they need quickly and confidently.
Asking, and answering, the following questions helps all team members collaborate smoothly within and across functions:
In the early stages of growth, the key is to keep it simple. Focus on adopting the right, uniform solutions and ways of working, and avoid an unnecessary proliferation of these items.
If you’ve worked for a growing, successful life science organization, chances are you’ve experienced the chaos. At Future State, we’ve helped dozens of life science organizations land on the processes, people, and tools needed to position themselves for their next phase of growth. With just the right dose of each of the three remedies discussed, your organization, too, will be ready for the increasing complexity that comes with more studies, more approvals, and more success.