Anticipating the Next Generation of Clinical Development Leaders

By Susan Oliver

In talking with clients and life science industry colleagues, I hear about decentralized clinical trials almost daily. Drug developers’ move toward DCTs – essentially, meeting patients where they are –  has been an opportunity to maximize their investments in clinical trials with efficiency, effectiveness and increased patient diversity.

There’s an important wrinkle that clinical development leaders must consider in relation to DCTs, however: technology innovation. How technology evolves around clinical trials will very much dictate the agendas of tomorrow’s clinical development leaders in pharma and biotech, and which individuals can succeed in this role. Currently, the technology/software/data market is overly complex and disparate, experts agree, creating inherent volatility in implementing solutions that are different for everything from trial site management to patient recruitment.

The next generation of clinical development leaders will be those individuals who not only have technical and scientific expertise but can help their organizations navigate these evolving technologies and select cross-functional, complementary solutions that meet their long-range strategic needs. As Andy Lee, co-founder, COO and CTO of Vincere Biosciences, recently told me, “Clinical development executives will need to speak the language of biology and technology.”

Visionary Clinical Development Leadership: Must Do’s

In light of this evolving technology landscape, there are essential steps that clinical development leaders must take in order to stay relevant and keep their initiatives at the cutting edge of industry practices. The following recommendations are informed by discussions with drug development leaders across the industry about current trial limitations and technological challenges.

• Commit to digital transformation. This is a commitment to the financial investment that digital transformation takes and also a commitment to technology innovation leadership. Digital transformation is expensive, complex and time-consuming. It is also key to deeper understanding of what is happening in a clinical trial, better patient access and engagement and faster drug development.

• Build the foundation within the organization. The challenges of digital and technological innovation precede any one specific clinical trial and include addressing outdated infrastructure and analytics, working through regulatory scenarios and meeting with regulators early to gain buy-in on technologies that add value to drug development. It also means creating a vision across the enterprise where clinical development leaders become part of innovation teams and/or innovation leaders become part of clinical development teams. This allows for the alignment of innovation objectives with clinical development objectives.

• Plan for the expanding importance of data scientists. This is no longer a role that is just about analyzing the data, but about collecting and managing the data that may be coming from a wearable device, a self-reporting patient portal, a healthcare delivery setting and trial sites. Drug development leaders should look for broad technology skills in their clinical developers, experts who can use and integrate disparate technologies to perhaps build a patient marketplace that allows individuals to self-select into clinical trials, and/or manage AI that uses EHR data to better match patients to a trial.

• Build the right team. Drug development is moving beyond columns and rows in data analytics and this requires new capabilities and skill sets. Innovative technology leaders with skills in high-performance computing, artificial intelligence, block-chain, etc. must be developed within one’s own clinical development teams. As search consultants, my colleagues and I have seen a distinct increase in the number of clinical development teams recruiting leadership in roles dedicated to data science, digital solutions, AI science and data management. Such experts already reside in other industries including advanced technology and even academia. Pharma and biopharma will need to attract these leaders and train them in drug development to reach clinical development goals.

• Adopt a digital mindset. In my conversations with pharma and biotech leaders at events such as the J.P. Morgan Healthcare Conference and the BIO CEO and Investor Conference, I have heard repeatedly that C-suites are embracing the concept of digital transformation. Nearly every big pharmaceutical company has a Chief Digital Officer, for example.

But the concept isn’t moving culturally or strategically into clinical development to the degree it should. Smaller biotech has done a better job of creating a digital mindset and culture from inception. But within larger pharma, innovation teams are typically separate from therapeutic area development. There isn’t a clear strategy for moving digital transformation pilot programs to broader clinical development programs. This makes it harder for clinical development to budget the adoption of new technologies. Leadership can bring change management expertise and education to the table to assist the enterprise in adopting new technologies by demonstrating how these solutions impact clinical trial outcomes.

Leadership Implications

In a recent article, my colleague Luigi Frezza cited research that indicates four out of ten biotech leaders are failing. Some of that is certainly due to the need for technology innovation skills in a changed clinical development environment. The competition for that talent will only become fiercer. It’s up to visionary clinical development leaders to get the resources and build the teams that will enable true technological innovation in drug development. 

With the potential for accelerated development cycles, drug development leaders must anticipate what unique abilities and skills their teams will need at each stage of clinical development – including data scientists – and adjust hiring accordingly. They must have a digital-first mindset that embraces new technologies with the understanding that they may have to cobble together multiple solutions to achieve the digital benefits they seek. Finally, the future of drug development requires leaders who think and act beyond traditional trial execution. This means collaborating with individuals across the organization and well outside the boundaries of typical clinical development. These forward-looking, cross-functional, data-driven leaders will be in short supply, and thus in great demand.