As a headhunter with an agency focused in hiring leaders for emerging biotech and device companies, I must maintain a solid understanding of hiring trends in the industry as well as the personality phenotype that can work well with the frantic pace of these emerging companies.
Perhaps one of the most critical executive hires that you need to get right for an emerging biotech or device company is the Chief Medical Officer. (CMO)
In a large biotech or device company you may find a CMO with a very strong therapeutic pedigree, prior head of cardiology at John Hopkins for example. This experience is invaluable when it comes to influencing key opinion leaders and plays well in both the clinical and medical affairs area. However this CMO may not have had any prior experience in front of an FDA panel bringing a product through the approval process. Additionally, if there had been any clinical protocol writing experience it may have been done long ago.
In an emerging company, CMO requirements are broader. I like to think of this job as the one where a person can beneficially employ any "ADD" personality traits; you have to be able to do a lot of things and do them very well with limited resources.
Assuming the CMO has strong leadership skills, this Chief Medical Officer has must also have these three attributes:
"Hands on" experience with protocol writing. Even if there is someone in the clinical group that can do this, the CMO needs to have an active part in writing the protocol. There is certainly the possibility that in a smaller company the CMO will be writing the entire protocol.
An established network with the key opinion leaders (KOL)s in the company's segment. The CMO will need to be influential with the KOLs in order to establish and maintain a rock solid foundation of trust.
History presenting in front of an FDA panel. The CMO will need to have had experience presenting phase III data or pivotal trial data to the FDA. Experience with an FDA approval is even better.
The other piece that is extremely important: Being comfortable working with limited resources in a "roller coaster" environment. All it takes is one investigator going off the handle to set a process off the rails. The CMO will be the one meeting the investigator and getting things back on track. This can be a tough thing for an MD to do because it means putting the "sales hat" on.
I mentioned in the second paragraph that the CMO is perhaps one of the most critical hires that an emerging biotech or medical device company can make. My experience holds that other than the CEO, it is the most important hiring decision. In my next blog I will detail why this is the case.