Despite the closing of major research facilities for global pharmaceutical companies, constrained funding for early-stage companies, merger and acquisition activity, and huge layoffs in sales, marketing and commercial functions, the war for best-in-class clinical development and regulatory affairs leadership shows no signs of letting up. As the pharma outsourcing community has expanded to broader services and deliverables during the last several years, so too has the demand for talent in these functional areas expanded dramatically at CROs and related third-party providers.

Clinical Development

The demand for new drugs — whether potential blockbusters, niche products or orphan drugs — remains unabated. Clearly this has added to the unprecedented pressure on basic discovery, preclinical and translational medicine functions, but it has also increased the stakes for molecules that reach the clinic. Unmet medical needs, market demands, the constant pursuit of new mechanisms of action, innovative biological approaches, adaptive trial design, and personalized medicine. These are all contributing to the demand for clinical development leaders who thrive on driving innovation to achieve success.

Whether it is a top five global pharmaceutical firm, midsize organization, startup biotech, or contract service provider, there are consistent professional and personal attributes presented by top-level clinical talent and demanded by the most attractive employers-of-choice. The highest standards of medical training, post-doc fellowships, and published research prior to joining industry are highly sought after. Individuals who present that background, combined with ever-increasing operational experience and strategic impact after joining industry, represent the gold standard by which top-tier employers judge potential senior clinical leadership talent.

As more midsize to global organizations have transitioned into complex matrix environments in the last decade, clinical leaders who have the ability to ‘connect the dots’ and effectively provide leadership across discovery, translational medicine, medical affairs, commercial and other functions are hugely valued. Additionally those physicians who have been awarded MPH MBA, and/or graduate accreditations and epidemiology, continue to be in growing demand by sponsor companies as well as CROs.

From a line management standpoint, now so more than ever, being an effective clinical development leader means far more than the already huge challenges of delivering trials on time and on budget. A-level clinical leaders must also demonstrate that they can nurture, mentor and develop the next generation of in-house clinical leaders.

The best clinical leaders in sponsoring companies also demonstrate the ability to shrewdly leverage outside resources beyond providers and CROs, to include highly productive collaborations with other pharma/biotech companies, academia, research institutes, NGOs, and more.

Regulatory Affairs

It has been increasingly clear over the last several years that the FDA, EMA and other regulatory bodies’ constantly shifting (and very often politically driven) approach to regulatory review and approvals will continue to create ‘moving targets’ for sponsors. Additionally, the aforementioned innovative approaches to drug development and new mechanisms of action are hugely impacted by regulatory requirements. So many of the current regulatory requirements pertaining to innovative technologies still need much further definition and clarity, to say nothing of the new clinical trial and post-marketing data these fields will generate in the coming years.

As such, the war for talent for regulatory affairs professionals has also increased during the last several years. The key drivers in A-level regulatory talent demand go far beyond the already-complex functional expertise in regulations, compliance etc.

The highest impact regulatory roles increasingly demand a strategic and proactive approach to working with the FDA, EMA, and other regulatory bodies in a professional, yet personal and relationship-driven manner.

Regulatory bodies themselves don’t have all the answers with regards to biosimilars, genetic-based personalized medicine, combination device/biologics products, regenerative medicine and the almost countless next-generation approaches to human healthcare. Key decision-makers at these agencies are very receptive to collaborative and engaging communications with the pharmaceutical, biotech, device and diagnostic companies they regulate. The demand in this area though is not for the people who just have contacts in the “good ol’ boy network,” but for true innovators who can really effect change and achieve results at regulatory agencies with next generation technologies.

Accordingly, sponsor organizations are hungry to recruit into their senior RA leadership posts these dynamic leaders who have a true proactive and relationship-driven approach to regulatory bodies in addition to ensuring regulatory compliance.

Best-in-class and high-in-demand senior RA leaders increasingly present very high quality scientific credentials prior to joining industry. They also demonstrate repeated patterns of driving regulatory success in innovative technologies, part of which was achieved by collaboratively driving regulatory innovation through the FDA and other agencies.

As previously mentioned regarding the in demand attributes of clinical leaders, a proven ability and verified success in having true positive impact across a complex matrix and developing and mentoring high-performing staff are also highly in demand attributes and common characteristics of A-level regulatory affairs senior leaders.

Moving Forward: Companies & Individuals

Chief executive officers and board members must be vigilant in assuring that their senior regulatory and clinical leaders are delivering functional as well as visionary expertise. If they are not, they can be assured that their best-in-class competitors are. Candidly, if A-level regulatory and clinical expertise is not in place, recruiting as well as retaining these individuals comes with a price. The most obvious price of course is the increased compensation it will take to attract these top-level performers that will likely be disruptive to internal equities. Beyond that however the true price of attracting visionary leaders is the buy-in that is required top to bottom in an organization that will create an internal environment where the only standard — is the highest standard.

Like leading-edge “disruptive technology,” innovative leaders in these functional areas very often “shake up” their organizations, but they also truly deliver value and position their companies for success. They must however be positioned in environments that recognize their value and award them a mandate to drive change.

Part of this buy-in must also be an organization’s dedication and support of clinical and regulatory leaders’ development of the next-generation decision-makers and unwavering support of mentoring and succession planning. The investment in in-house talent in these areas has quite often been relegated to secondary priority status. As with high-performing leaders, high-performing companies clearly see the value in investing in human capital and the tangible, if not always immediate, payoff that it delivers.

If you are currently a regulatory or clinical leader who meets the above-mentioned descriptions, you have probably lost count of the amount of times in the course of an average week that you get called by recruiters. It is likely though that the drive, passion, focus and dedication you poses often leads you to not taking a moment to learn more about select external outside opportunities.
Analogous to the amount of drug candidates in a pipeline that actually come to approval, the simple fact is that there are statistically very few truly high-quality attractive opportunities in the marketplace, compared to run-of-the-mill openings. One of the marks of success we have seen though with high-performing leaders is the balance they strike between focusing on their tasks at hand but also being receptive to opportunities which may not only advance their careers but may also be extraordinarily unique. There is a big world out there — take the recruiter’s phone call, and take the blinders off!

The demand for high performing clinical and regulatory talent is projected to continue — if not increase — during the next several years. Those organizations that establish best-in-class standards for talent in these areas will reap the benefits, provided their investments and commitments to those high standards are unwavering.

As such, A-level senior leaders in these areas are going to be positioned to continue to have huge impact within their companies and also driving forward next generation industry and regulatory practices. If they also manage their career with the same level of forward thinking, they will also be positioned to reap the benefits of personal gratification, career advancement and financial rewards.

Victor Kleinman is Global Life Sciences Technology Practice Leader for DHR International. He can be reached at [email protected].