Physicians and other BioPharm clinicians often hold executive positions as company President or CEO, or as Chief Medical Officer (CMO), or Vice President of Clinical Research or VP of Medical Affairs, or VP of Regulatory Affairs. Doctors in these roles live in two worlds, business and clinical.
CEO's
Many physicians who become CEOs start out as scientists in Discovery or Development and rise to a leadership position in their company or get hired away by another firm. An alternative way to become CEO is to start your own company. Because I work in the San Francisco Bay area and have helped many small start-up companies design and conduct their first clinical studies, I’ve met several physician-CEOs.
Let me tell you about one, a successful CEO who did not start out in BioPharm or even in medicine. When he finished college he went to work on Wall Street. Although he was successful, he decided something was missing, or rather that he was missing something. He wanted to make a difference in people’s lives. He went to medical school, completed a residency in psychiatry and joined a large academic medical center. He observed remarkable improvements in a few patients with severe depression who were treated with a drug that was on the market for a different -- quite a different indication. He and a colleague formed a company to develop this drug for treatment of depression. I first met him when he came to my consulting company for help in filing an IND and starting clinical studies. That was almost 20 years ago. Since then he has been successful, but not as he imagined. Despite promising early results, his company was not able to get their drug approved for treatment of depression. But along the way he lessened the risks for the company by testing the drug for other indications. Their first drug had some unwanted side effects. So, he hired staff to develop new drugs with similar, but more selective, activity. He now has a successful company with an approved product on the market for an orphan indication, several promising clinical studies for other indications, and a group of new drug candidates.
Another successful CEO that I've worked with is a physician who left academia and started a biotech company to develop drugs to treat connective tissue disorder. In order to keep the company solvent while working on basic research, he licensed in an approved product for marketing and generated income for the company. The company grew and was later acquired by a larger firm. In the meantime, he developed an independent, non-profit research organization to study the molecular and cellular basis of autoimmune and connective tissue diseases. He used this research group to assist start-up companies with Discovery and Development. His research institute supports a group of scientists working to understand disease pathways and concurrently provides an environment for the incubation of other research-based companies, a unique niche.
CMO's
The role of Chief Medical Officer may differ from company to company. Many companies do not used the title at all. In others, the title is given to the most senior physician in the research division. Other companies create a special role for a senior advisor who may focus on both research and marketing-related activities. Many people see CMO's as the chief link between the company and the physician and patient community.
VP of Research, VP of Medical Affairs
Depending on the size and structure of the company, the VPs of Research or Medical Affairs may act primarily as administrators with responsibilities for staffing, supervising and budgeting and they may retain some monitoring or writing activities. They usually interact with Regulatory and Safety groups and serve on Executive Committees.
CEO's
Many physicians who become CEOs start out as scientists in Discovery or Development and rise to a leadership position in their company or get hired away by another firm. An alternative way to become CEO is to start your own company. Because I work in the San Francisco Bay area and have helped many small start-up companies design and conduct their first clinical studies, I’ve met several physician-CEOs.
Let me tell you about one, a successful CEO who did not start out in BioPharm or even in medicine. When he finished college he went to work on Wall Street. Although he was successful, he decided something was missing, or rather that he was missing something. He wanted to make a difference in people’s lives. He went to medical school, completed a residency in psychiatry and joined a large academic medical center. He observed remarkable improvements in a few patients with severe depression who were treated with a drug that was on the market for a different -- quite a different indication. He and a colleague formed a company to develop this drug for treatment of depression. I first met him when he came to my consulting company for help in filing an IND and starting clinical studies. That was almost 20 years ago. Since then he has been successful, but not as he imagined. Despite promising early results, his company was not able to get their drug approved for treatment of depression. But along the way he lessened the risks for the company by testing the drug for other indications. Their first drug had some unwanted side effects. So, he hired staff to develop new drugs with similar, but more selective, activity. He now has a successful company with an approved product on the market for an orphan indication, several promising clinical studies for other indications, and a group of new drug candidates.
Another successful CEO that I've worked with is a physician who left academia and started a biotech company to develop drugs to treat connective tissue disorder. In order to keep the company solvent while working on basic research, he licensed in an approved product for marketing and generated income for the company. The company grew and was later acquired by a larger firm. In the meantime, he developed an independent, non-profit research organization to study the molecular and cellular basis of autoimmune and connective tissue diseases. He used this research group to assist start-up companies with Discovery and Development. His research institute supports a group of scientists working to understand disease pathways and concurrently provides an environment for the incubation of other research-based companies, a unique niche.
CMO's
The role of Chief Medical Officer may differ from company to company. Many companies do not used the title at all. In others, the title is given to the most senior physician in the research division. Other companies create a special role for a senior advisor who may focus on both research and marketing-related activities. Many people see CMO's as the chief link between the company and the physician and patient community.
VP of Research, VP of Medical Affairs
Depending on the size and structure of the company, the VPs of Research or Medical Affairs may act primarily as administrators with responsibilities for staffing, supervising and budgeting and they may retain some monitoring or writing activities. They usually interact with Regulatory and Safety groups and serve on Executive Committees.