My first job was as a research manager, not unlike the previous two jobs at Abbott and Allied. My job was to manage a group of scientists and technologists developing new immunoassay products for cardiac and cancer diagnostics. This company was fairly young, so a significant amount of discovery research was required for the company to understand its own technology and to produce reliable products. I was faced with the challenge of trying to further the technical development of each of three new products while learning the technology and quickly understanding the technical and organizational issues ahead.
I was brought into the organization at a middle management level. I quickly learned that others in the company felt that they should have been candidates for my job since they had been with the company for a long time and they felt that they had the qualifications. This did not make my job easy when interacting with these individuals. This was a new kind of interpersonal challenge that I hadn't encountered before. Dealing with and diffusing this resentment, in addition to the typical transition into any new job, required me to be in top form, both technically and managerially.
About 1 year into this new job and company, I came to seriously reflect on my job and career. Although my love for science and the product development application of science had not waned, I was sensing a need for a change. I started to explore other job functions in the company, which would allow me to apply my technical education and my prior experience, which would be fulfilling, and would not cause me to question if I were "selling out" on my academic training to be a laboratory scientist.
An opening came in the clinical and regulatory department, and I approached the departmental vice president, asking to be considered for the position. I got the job thanks to my past, although limited, experience in conducting clinical studies at Abbott and, more importantly, thanks to my analytical training at the Ph.D. level. Hybritech management held the view that a Ph.D. scientist working in clinical research was key to addressing the complexities of clinical trial design and data analysis, and could interact effectively with clinical investigators, most of whom were M.D.'s or Ph.D.'s. My technical training was expected to improve my interactions with these clinical collaborators.
Although Hybritech had been in business for about 10 years, the Clinical Affairs area was much undeveloped. I was required to learn all facets of the job on my own, and to build the department from the ground up. This included hiring new people and developing processes so that the new department could conduct good clinical trials. I knew that I could apply my skills in devising experiments in the lab to developing clinical trial protocols. However, I lacked depth of knowledge about the various disease areas to which our products would be applied and how to develop a specific clinical protocol for each product. A rapid learning curve ensued on my part. This came from reading the clinical rather than the scientific literature and in actually meeting with and talking to clinical researchers. I also quickly came to appreciate that knowledge of FDA regulations and, more importantly, their interpretation, was important to the success of my clinical trial endeavors.
An amalgamation of my past experiences and of this new knowledge launched a different direction for my career change to clinical research. I also had an interest in people management, which over the next couple of years led me to position myself for a director-level position for both the clinical and regulatory departments. I continue to find both technical work and managerial work rewarding and challenging.
In my current position, I find that my basic education in biochemistry and an aptitude for systematic and analytical thinking have allowed me to handle most new technical areas or projects. I still do try to keep up with basic scientific literature and, of course, I continuously read the clinical literature in those medical areas that apply to our products.
I find it rewarding and renewing to interact with the research and development scientists so that I can stay current in the technical developments within our company and outside of it. This keeps me in touch with basic science. I've been exposed to some good role models in supervisors who have had strong managerial skills and I've tried to apply many of these skills to my own management style.
Where Do We Go From Here?
So what is the future for my career? I can see other opportunities to do the same type of clinical work but in another type of institution. Clinical research organizations (CROs) are for-profit entities that provide clinical trial services to pharmaceutical and diagnostic manufacturers. They do not manufacture pharmaceutical or diagnostic medical products.
CROs have staff members with clinical, regulatory, data management, and statistical experience who take on the clinical or regulatory work that a company does not perform on its own. This may involve hiring CRO personnel to monitor multiple clinical trial sites. The CRO may assist in the data collection process from each site and then they might perform the data analysis. Depending on the complexity of the trial and the in-house expertise of the client company, the CRO and its staff supplement one or more corporate functions to assist in completing the clinical development of a new product.
The jobs available at a CRO do not differ markedly from those within a company where clinical research takes place. Thus, similar positions and job opportunities are offered for individuals with science, computer, or statistical backgrounds. One key difference is that a manufacturer typically has a stream of products that are developed internally or are acquired from outside of the company, each of which requires clinical research before they can be brought to market. A CRO, on the other hand, conducts clinical research with whatever type of product a client brings to them.
As a CRO employee you may be asked to work on products in only one disease area in order to focus the CRO's expertise, or you may work on many products, no two of which are in the same disease area.
Compensation for a position with a manufacturer or with a CRO varies widely, depending on whether the position is within a pharmaceutical or a diagnostic manufacturing organization. Pharmaceutical companies typically pay more than do diagnostic companies for all levels of clinical trial personnel. CROs are competitive with pharmaceutical companies. East Coast-based companies-manufacturers and CROs alike-typically pay higher salaries than do those on the West Coast. Salaries for entry level clinical research positions can range from $30,000 to $50,000, while those at the scientist or more senior levels range from $55,000 to $90,000 or more. Good sources of training and networking to facilitate an entry or transition into clinical research work can be found in a number of societies. These organizations hold national and regional meetings once or twice a year and they offer courses and seminars on various clinical research and regulatory topics. One such organization is SOCRA, Society of Clinical Research Associates. This is an excellent group within which to network since all of the attendees represent manufacturers or CROs that do clinical research work. Other groups of similar value include Barnett-Parexel, which offers many courses on the different facets of clinical research and these are scheduled on both the East and on the West Coasts, and the Drug Information Association (DIA), which also schedules national and regional meetings on pertinent clinical trial topics.
What It Takes
In looking back and also to the future, I've found that my analytical and scientific training and my ability to do critical thinking are of utmost importance in performing my job successfully. I believe that these skills have applied to all of the technical and managerial jobs I've held. In addition, communication skills, both speaking and listening, are important in making yourself understood and in understanding the input of others. Without good communication, things are not clone efficiently and many interpersonal misunderstandings develop, creating tension and a negative work climate.
The ability to juggle many projects is the key in today's working world, and this will continue to be the case in order to be successful in industry. Resilience and perseverance are handy traits that will help you withstand disappointment, confrontations, and criticism of your own shortcomings at times.
Starting with a good foundation in some type of scientific or technical training can position you well for a variety of jobs that are rewarding and challenging, and that will validate your decision to pursue an alternative scientifically based career.
