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When the draft sequence of the human genome appeared in 2000, pharmaceutical and biotechnology executives anticipated an increase in drugs approved for the marketplace. Instead, the reverse happened; the number of new drug approvals by the US Food and Drug Administration declined until 2004. And although 35 new drugs were approved that year, only 20 new drugs reached the US market in 2005. Drugs rarely sail through clinical trials, the safety and efficacy tests that determine whether a drug will reach the market and stay there (see 'Clinical trials step by step'). Before 2000, drugs entering the first stage of testing on humans, known as phase I trials, had a 14% chance of reaching the market; today that figure is a mere 7%.
Ample opportunities: Chris Jock says there is high demand for clinical-research scientists.
Because companies are having such a difficult time getting drugs approved, scientists adept at planning, running and managing clinical trials will find themselves awash with opportunities. The global growth of contract research organizations (CROs), which help drug companies with preclinical work and clinical trials, combined with increased scrutiny of clinical trials, adds up to ample job opportunities. "There is high demand, but a very constrained labour pool," says Chris Jock, vice-president and general manager for global operations at Kelly Scientific Resources, Troy, Michigan. Increased emphasis on regulation, pressure to produce data faster, the opening of the global market and a shift towards generics has put unusual pressure on the drug industry. This supply–demand imbalance is unlikely to vanish in the near future, says Jock.
Among the many professionals who participate in clinical trials (see 'Stats and stories'), two key positions provide most support: the clinical research associates (CRAs) and the more senior clinical research scientists. "We recruit heavily for both positions," says Steven Smith, director of human resources and development at Novartis in East Hanover, New Jersey. Both generally demand a background in life sciences and excellent communication skills.
The CRA, or 'field monitor', checks the clinical study from start to finish — identifying the doctors who can find volunteers, educating them about the study, doing the paperwork and ensuring that supplies are on hand. CRAs should be willing to travel as a lot of time is spent visiting trial sites. "They are doing the blocking and the tackling of clinical-trial execution," says Chip Clark of Vanda Pharmaceuticals, a small firm in Rockville, Maryland, that applies genomic and genetic tools to undeveloped drug compounds to try to find unexpected indications or more appropriate patient subpopulations.
Once the trial begins, the field monitor checks the data for significant adverse events, notation errors and omissions, before passing them along to the data-management group. More senior CRAs may also write protocols, abstracts and manuscripts.
For the clinical research scientist, the job focus lies in trial design. They assist doctors and coordinators with the trial, provide training, aid in data collection and may work with the regulatory-affairs team. Doctoral degrees in the biological sciences are common among this group. "They are the internal contact for the investigators, there to assist if there are questions about the protocol, the dosing or payments. They are the heart," says Lisa Jean-Louis, associate director of clinical research at Novartis.
The right skills
Three to five years' clinical or industry experience may open up more senior positions. Applicants with less experience should maximize their networking, or take extra courses or certificate programmes through industry associations, such as the Association of Clinical Research Organizations or the Society of Clinical Research Associates, says Leslie Eggleston, manager of corporate staffing at Otsuka Maryland Research Institute in Rockville, Maryland. An internship at a drug company can provide young scientists with a foot in the door.
Project management is the other main track. "Project managers often have a life-science background, but they are focused on processes and leading teams," says Sam Bidwell, senior vice-president of human resources and global product development services at Quintiles, a CRO based in Research Triangle Park, North Carolina. The project manager's responsibilities include site selection, feasibility studies, customer relations, budget planning and data management. "A business background is preferred, but the science background will facilitate their understanding of the processes," says Eggleston, adding that these positions are often difficult to fill.
The profile of an ideal candidate depends largely on the sector. Although pharmaceutical companies, biotechs and CROs all rely on professionals to take a drug compound through clinical trials, they vary in the number of positions available, the responsibilities and the experience required. Candidates stand out if they have expertise in a specific therapeutic area, especially if the study has already started. "It means only getting them acclimated to the Novartis ways, not having to train them in diabetes," says Jean-Louis.
Pharmaceutical companies may have extensive in-house clinical-trials staff, or maintain a smaller team of clinical research scientists and project managers to work with the CRO. Smaller companies can offer a career with greater visibility, independence and responsibility, but they may have more stringent hiring requirements. "We are being very careful about who we hire because we are just 35 people," says Clark. "One bad hire would stick out like a sore thumb. We really need to get the first 50 or 60 people right." Small biotechs often hire people from drug firms.
Well connected
Most of the growth in the job market lies with CROs. Worldwide, the CRO market is worth about $15 billion this year, and its revenue is increasing at an annual rate of about 15%. CROs are known for their speed and efficiency; they can complete a clinical trial in two-thirds the time a drug company can, shaving months off the process and offering $120 million to $150 million in increased revenue per drug. Small or medium-size drug firms and biotech companies know that the farther the compound moves through the research cycle, the more money they can raise. "Of the top 30 best-selling drugs, we've touched every one," says Bidwell.
The CROs have global reach, recruiting trial subjects at speeds often unmatched by drug companies (see Nature 441, 22–23; 2006). According to the Center for the Study of Drug Development at Tufts University in Boston, Massachusetts, nearly one-third of US drug trials are conducted abroad. Smith estimates that 60% of Novartis's trials are run overseas, in Europe, Latin America and more recently India and China. Eggleston notes that it can be difficult to find US candidates with the necessary foreign experience. Bidwell says that Quintiles has employees in 53 countries around the world and hires many local monitors.
Altogether, the job market in clinical trials is so hot that a well-qualified candidate can choose among thousands of positions available globally, and has a fair chance of landing one within a month.
Clinical trials step by step
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Phase I trials evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of a drug in 20 to 80 volunteers. Most phase I clinical trials are conducted in an in-patient clinical setting on healthy volunteers.
Phase II trials measure the drug's efficacy in 100 to 300 volunteers and patients.
Phase III trials comprise 1,000 to 3,000 volunteers, or even more. The trial is often double-blind, randomized and controlled.
Phase IV trials involve post-launch safety and surveillance of a drug, to detect rare or long-term adverse effects.
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Stats and stories
Biostatisticians are a key piece of the clinical-trial puzzle, although they often go unnamed. "We generate reams and reams of data and we have to be able to interpret them," says Evan Loh, vice-president of Clinical Research and Development at Wyeth Pharmaceuticals in Madison, New Jersey. But the job goes far beyond sorting data. "When doing hypothesis-driven research, you have to prospectively design your hypothesis and your analysis tools in order to interpret the data in a non-biased way," says Loh. A background in a biological discipline can be a plus, but is rarely required.
It takes about 12 years for an experimental drug to gain approval from the Food and Drug Administration — six of these years are spent in clinical trials. Without talented medical writers, all this work is wasted. These writers plan, write and edit study reports, manuscripts and other related clinical documents. They frequently hold advanced scientific or medical degrees and have some academic or industry writing experience.
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