Which jobs are the most sought-after in the biotech
world? Clinical development and regulatory affairs jobs, according to two
biotech staffing experts: Victor Kleinman, executive vice
president and managing director of the Life Sciences practice at DHR International, and Tom Murphy, senior vice
president of life science recruitment at Solomon
Page Group. Kleinman and Murphy each have 20-plus years of experience helping
biotech and pharma companies meet their staffing needs. And both have insider
knowledge on how trends in the industry are affecting the hiring demands in
biopharma.
Kleinman says that many smaller companies
looking for talent are young biotechs led by a CSO or founder. These
companies and their investors have often completed basic research and have
arrived at a point in their drug's development that calls for rounding out the
management team. Developers may find themselves in need of skills from different
functional areas, or for an executive with strong leadership skills.
"Clinical development and regulatory affairs
are the hardest positions to fill because they are the highest in demand,"
explains Kleinman. "Even if you're not setting the world on fire,
you're getting calls from recruiters several times a week." Murphy agrees
with Kleinman's assessment. "We're getting the most calls for experts in
clinical development, medical affairs and regulatory affairs. That's the
pathway where companies make and break their firms," he explained in an
interview with FierceBiotech.
Demand
for clinical trial experts
Prior to the industry's rapid consolidation, many
MDs were reluctant to leave their safe positions at a Big Pharma company.
But over the last several years, the biggest players have been laying off
thousands of jobs and even entire therapeutic groups. "Everyone who's in a
big company realized the consolidations are huge, and Big Pharma isn't the safe
haven it once was," notes Kleinman. Small companies are in hot pursuit of
physicians and regulatory affairs experts with industry experience. But Murphy
stresses that having the right background doesn't necessarily ensure that an
ex-pharma employee will be a good fit for small biotech.
The need to fill these positions has grown over the
last five years or so. Companies of all sizes are facing generic
competition, patent expiration and dry pipelines. Combined with more scrutiny
from the FDA and the changing face of healthcare in the U.S., these factors
have driven up the demand for clinical jobs, particularly in the oncology, CNS,
cardiovascular and vaccine areas. There's enormous demand for medical experts
who are qualified to design and run trials. Expertise in trial design is particularly
important--developers are desperate for leaders who can design better, more
efficient and less expensive trials that will still survive the FDA's rigorous
review process.
"If you have the leadership and management
skills, and risk profile, you can really have some fun at a small biotech.
You're one of just a couple of people leading the clinical studies," as
compared to Big Pharma, which has whole teams involved in that process.
"You get a much greater exposure to a management team as well,"
Murphy says. But he stresses that the small biotech job isn't for
everyone. Murphy explains that many physicians who end up in Big Pharma are
risk-adverse, making it a shocking culture change to move to a small company.
Physicians who move into start-ups "have to be much more hands-on, and
willing to roll up their sleeves."
Dealing
with the FDA
Developers have equally high expectations for their
regulatory affairs recruits. It used to be that a good regulatory affairs
person just had to understand the FDA's rules. Now, in a world with
biosimilars and increased focus on drug safety, the FDA itself doesn't even
know the rules. "You need strategic-thinking heads of regulatory affairs
who can work with the FDA in a professional way to develop a collaborative
relationship with agency heads," says Kleinman. Achieving that kind
of relationship takes a tremendous amount of strategic thinking, regulatory
knowledge and people skills.
Murphy recommends that the people most suited for
regulatory affairs work at a small biotech be comfortable operating in the gray
area. "In a small company you need a problem solver, someone who can
handle all the moving parts." Working on a new program in the
regulatory pathway may not always be as clear as management would like. That's
because the political climate at the FDA rocks back and forth between safety
and quick approval of new drugs, explains Kleinman, causing many companies to
feel as though they're trying to hit a moving target when it comes to meeting
the agency's demands. "The industry is searching for regulatory
people who understand the market factors facing the FDA and who can be
proactive and savvy of the FDA's mood," Kleinman observes.
Big
Pharma
Just like small biotech, Big Pharma has certain
sought-after candidates on its "must-hire" list. In the last several
years, Kleinman says his firm has been contacted by Big Pharma to
fill brand new positions that didn't exist before for one of two reasons.
First, a mega-merger may have created a new therapeutic area or position that
suddenly becomes the prime focus of a combined company. Also, pharma looks for
assistance when it's entering a totally new scientific or medical area. Ten
years ago, he says, his company was asked for assistance in filling a number of
translational medicine positions. Five years ago, Big Pharmas were looking for
experts in personalized medicine. The latest demand is for biosimilar experts.
Calls are also coming in for executives with experience in rare diseases,
orphan diseases and emerging markets.
The pharma industry has been rocked by massive
layoffs in the last several years. But for those with clinical or regulatory
expertise in sought-after therapeutic areas, there's an opportunity to play a
pivotal roll at up-and-coming biotech companies.
FierceBiotech
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