Clinical Research organizations offer wide range of management opportunities for physician executives

Physician Executive, Jan-Feb, 2005 by Ross Tonkens

The largest CROs employ physicians representing a broad range of specialties, offering their clients depth of expertise in the specific disease entities their products are intended to treat. Because CROs bid against one another for business, CRO physicians are called upon to assist with bid development and to participate in the actual sales presentation (called a "bid defense") to the potential client (called a "sponsor").

Generally, at any one time the CRO physician juggles half a dozen or more compounds or devices for different companies through various stages of development, serving as an advisor to the PIs conducting the clinical trials, to the CRO staff managing the trials and to the sponsors themselves, all the while carefully monitoring the safety of volunteers receiving the experimental agents.

For every clinical development program in which he participates, the CRO physician will usually attend one or more investigator meetings where he will recap what is already known about a new compound or device, explain the research protocol in detail and field questions from the PIs who have been flown in to learn in detail about the trial they will be conducting.

As one clinical trial reaches its conclusion, new bids are being developed and defended, and new clinical trials are continually commencing. This environment provides the CRO physician with a broad range of experience in the problems unique to developing drugs and devices for his particular specialty.

Through these varied experiences, the CRO physician is generally exposed to many more opportunities to gain a comprehensive understanding of the economics of the pharmaceutical, biotechnology and medical device industries. The CRO physician may co-author a peer-reviewed journal article after overseeing a particularly significant clinical trial or provide comment on behalf of the CRO to a government agency on a proposed regulation or policy affecting the drug development and approval process.

Broad expertise

Developing such varied expertise can be tremendously satisfying for the CRO physician while making him all the more valuable to his employer. Sponsors often request advice on how best to proceed with a multi-million dollar drug or device development program in order to maximize the likelihood of approval.

CRO physicians perform these consultations routinely, researching the market, the competition, and the historical regulatory requirements for approval of similar products, consulting opinion leaders, and writing reports with recommendations on how best to develop the sponsor's product.

Sometimes this leads to the CRO physician writing a research protocol for the sponsor as well. Since a variety of new projects constantly replace completed ones and the CRO physician, like an attorney, generates income (billable hours) for his employer, job security is high for the CRO physician.

Physicians working at Quintiles share their knowledge by creating and teaching courses in their respective fields of expertise for an internal university. Quintiles physicians are enlisted, as well, to assist with curriculum development for the company's education division that offers continuing medical education to practicing physicians.