Is Another Degree Necessary After Your PhD?

Posted in Career Advice

There was an interesting article in Science Careers Magazine this week entitled “Should you consider another degree after your PhD.” The article traces the journey of several people who earned PhD degrees in science-related fields who transitioned into new careers including law, regulatory affairs, business development and science writing.

The gist of the article is that if you can afford the costs of earning another degree, it may be worth it for persons with PhD degrees who want to get “out of the lab.” However, based on my own experiences and those of the persons mentioned in the article, most graduate students and postdocs lack the financial resources to enroll in professional degree or certificate programs after completing their PhD programs. Consequently, most of the people showcased in the article were able to leverage unpaid internships and volunteer work into new jobs that paid for additional training or professional degree programs.

I have long posited that obtaining another degree after a PhD degree may not be in a  best interest of PhD degree holders for a variety of reasons. First, as mentioned above, the financial obligations of a degree or certificate program may be too onerous  or unrealistic for graduate students who worked for minimum wage for many years to obtain their PhD degrees; the funds simply are not available. Second, by the time a PhD degree is award and postdoctoral training is completed, most science PhD degree holders are in their mid 30s to early 40s and ,in many cases have families,which may not be conducive to going back to school full time. Also, who wants to be a student for most of their adult lives? Finally, the mere exhaustion and stress associated with spending close to 10 years in a laboratory may discourage even most ambitious individuals from pursuing another degree or certificate. Put simply, there may not be “enough gas left in the tank” to obtain another degree in the hopes of possibly a changing a career trajectory.

Based on my experience as an instructor in a program offered to PhD students and postdocs who had already decided that a research career was not for them, internships, volunteer work and an unrelenting pursuit of an alternate career is probably the best way to navigate a career change. What I observed about all of the students in this program (over 70% of them obtained non-research jobs after completing their PhD degrees with no postdoctoral training) was that they were highly motivated and did whatever was necessary to network and leverage the resources offered to them by the program (which included mixers, invitations to professional meetings, and guest speakers outside of the research world including pharmaceutical executives, venture capitalist, medical writers and clinical study managers) to get “where they wanted to go”.  For example, one student, who was interested in regulatory affairs, went to the dean of her medical school to get the funds necessary to go to a national regulatory affairs meeting rather than attending an annual society meeting to present her research findings. Today, she is a director of regulatory affairs at a major biotechnology company. Another student, wrote reviews for an online financial services company regarding the technology behind various private and publicly traded biotechnology companies as a graduate student, now works for a financial service company as an analyst. Finally, another student who was interested in technology transfer was able to leverage an unpaid internship in his university’s technology transfer office into a full time job (he is now a director of the office).

The bottom line: while obtaining another degree or certificate may better position you for a possible career change, it may not be emotionally or financially possible or likely. That said, rather than fantasizing about what may have been if you simply chose law or medicine or business over a graduate career in science, you best shot at changing the direction of your career may be to identify alternative career options and obtaining the necessary skillsets, qualifications and real life experience to make it a reality, Once you have identified those things, the next step is to devise a financially-viable plan to obtain them and then spend the majority of your waking hours successfully implementing the plan. It won’t be easy but as the old adage goes “if there is a will then there is a way.”

Until next time……

Good Luck and Good Job Hunting!!!!!!

 

So You Want To Be A Regulatory Affairs Professional?

Posted in BioEducation

As anyone who works in the drug development industry and they will invariably tell you how complex the environment has become in the past 10 years to get a new drug or medical device approved. While this increased regulatory scrutiny has been brought on by drug and device makers themselves (has there been a time over the past decade when there has not been some reports in the news media about drug recalls, tainted drugs or marketing scandals?), it does not obviate the growing need for more regulatory affairs professionals at drug and medical devices companies. To that end, people looking to break into the life sciences industry ought to consider whether becoming a regulatory affairs professional may be right for them.

Zachary Brousseau, who is Senior Manager of Communications for the trade group the Regulatory Affairs Professional Society (RAPS), alerted me to a recent annual survey conducted by the group entitled “Global Scope of Practice and Compensation Survey”. This survey which has been conducted by RAPS for the past 20 years provides insights into the regulatory affairs profession and the compensation persons interested in this career might expect.

I highly recommend those of you who are considering regulatory affairs careers to read the post below and to also look at the entire survey. Also, RAPS offers traditional classroom and online courses for those who are looking for training to break into the profession.

RAPS Scope of Practice Study: Tracking the Regulatory Profession

RAPS recently fielded the 2012 iteration of its ongoing research initiative on the regulatory profession, the RAPS Global Scope of Practice & Compensation Survey.

This research has been conducted by RAPS for more than 20 years, and it continues to be the largest, most comprehensive study of the healthcare product regulatory profession. RAPS Executive Director Sherry Keramidas, PhD, FASAE, CAE, recently spoke with Regulatory Focus about the study and its implications.

Regulatory Focus (RF): What is the goal of the Scope of Practice Survey?

RAPS Executive Director Sherry Keramidas (SK): The Scope of Practice Survey gives us a look at the development of the regulatory profession, monitoring trends and changes in what we call the scope of practice: the duties and responsibilities of regulatory professionals. It also gives us a look at their career progression and compensation.

RF: Why is it important?

SK: Like any profession, the regulatory profession must adapt and evolve. This research provides a way of seeing how it has adapted and changed over time, and gives us insight that helps regulatory professionals respond to the changing needs and anticipate what may be coming next. What we learn helps RAPS create and improve professional development initiatives to ensure regulatory professionals have the knowledge and skills to excel in their roles today and tomorrow. It also provides critical information for RAPS to help the world beyond the profession understand what regulatory professionals do and its importance.

RF: What have you learned about the regulatory profession from previous surveys and what do you expect to learn from the current survey?

SK: We have seen a number of important developments over the 20-plus years we have been conducting this research. We have seen increased movement of professionals across product lines—from more pharma-oriented jobs to medical device jobs and vice versa, and we have witnessed increased involvement in combination products. We have seen a trend away from country-specific specialization to more professionals who have multinational or worldwide responsibilities. And we see strong similarities in the scope of practice of professionals around the world, regardless of where they live and work. Today’s regulatory professionals have to be more familiar with regulations and requirements for many different global markets and different products. There is still specialization, certainly, but there is an increasing need for regulatory professionals to understand the broader regulatory landscape. Another interesting development has been that regulatory professionals have become more involved in business and strategic decision making. I would expect each of these trends to continue.

RF: What do you think is driving the increasing involvement in business?

SK: The shift toward more business involvement is something we started to see more than 10 years ago. I think the increasing number of regulatory professionals ascending to higher executive levels played a role in companies’ and organizations’ burgeoning recognition that regulatory expertise can provide valuable insight to drive more-effective organizational strategies. The fact that regulatory professionals were increasingly being called upon to influence business and strategy decisions led RAPS to launch its Executive Development Program in partnership with the Kellogg School of Business at Northwestern University. That is a pretty good example of how this research helped RAPS identify and respond to a growing need within the profession.

RF: What other changes in the profession have you seen, and what do you think is driving them?

SK: Another trend and an important factor, I think, in the business involvement has been regulatory’s increasing engagement throughout the product lifecycle. This made regulatory professionals more important players in all aspects of healthcare products—from research and development through postmarketing. Regulatory has a role at every stage, whereas years ago, the emphasis for regulatory professionals was on submissions and compliance. This change aligns with what is going on in the overall the healthcare product sector. In recent years, we have seen industry’s focus shift a bit toward more postmarketing activities and keeping existing products on the market.

RF: Have there been any surprising results from past years’ surveys?

SK: I don’t think we expected to see the business involvement when it first emerged. Other interesting trends we have seen develop include increased engagement in reimbursement and health technology assessment. Issues of regulation and reimbursement are more often being considered in coordination with one another at earlier stages. A viable product needs to be both approvable and reimbursable, and regulatory professionals are increasingly being asked to help bridge the gap between the two areas.

RF: What new questions have been added to the survey this year? What do you hope to glean from these questions?

SK: We have refined the breakdown of where regulatory professionals spend their time based on feedback from those in the field, and we have added some new questions about what brought them into the profession in the first place and what factors help shape their career decisions. For organizations that employ regulatory people, there is a need to find the best way to recruit, develop and retain regulatory professionals. More information will help both professionals and employers better address career development and talent management.

RF: What can the Scope of Practice survey tell us about the importance of the regulatory profession?

SK: The profession continues to evolve closely in step with the overall healthcare product sector, including the pharmaceutical, medical device and biotechnology industries. Translating scientific and technological breakthroughs in these areas into real, accessible patient treatments demands that regulation keeps pace. In many ways, the regulatory profession is on the cutting edge, at the intersection of innovation, regulation and business. There is a growing recognition of the critical role of regulatory professionals, even as work remains to help those outside the profession more fully understand what they do. Regulatory professionals do important work that, as RAPS’ tagline says, ‘helps make better healthcare products possible.’ The Scope of Practice Study helps us tell this important story.

The 2012 RAPS Global Scope of Practice & Compensation Survey is open now, and regulatory professionals can complete it online at www.raps.org/2012globalstudy.

Until next time

Good Luck and Good Job Hunting!!!!!!!

 

Boston-Based Life Sciences Job Opportunities

Posted in BioJobBuzz

Interest in the diagnostic sector of the life sciences industry began to wane shortly after development of a test for HIV in the 1980s. However, the emergence of molecular diagnostics and personalized medicine coupled with the 2001 anthrax attacks and the SARS outbreak have helped to reinvigorate this sector. In fact, the diagnostic industry is one of the fastest growing segments of today’s life sciences industry. 

For those of you who may not know, diagnostics tests are regulated in the US as medical devices not therapeutic entities. And, for the most part, the regulatory approval process for diagnostic tests is less stringent and quicker than that required for FDA approval of new therapeutic agents.

Unlike most pharmaceutical and biotechnology companies, companies focused on developing new diagnostic products are hiring. Boston-based Immunetics, a diagnostic company that focuses on developing tests to detect viral and bacterial pathogens including HIV, anthrax and others, is currently looking to hire a regulatory affairs and sales and marketing professional (Product Manager). 

The requirements for the regulatory affairs position can be found here whereas the qualifications for the sales and marketing opportunity can be found here. Neither of the two positions requires a PhD degree. However, persons with PhD degree who possess a strong background in regulatory affairs or pharmaceutical sales and marketing experience will be considered.

For those of you PhD degree holders out there, getting additional training in regulatory affairs or sales and marketing (for those with a business bent) would be extremely useful for those of you seeking employment in the life sciences or medical devices industries.

Until next time…

Good Luck and Good Job Hunting!!!

 

FDA Inspections: Insights into Responding to FDA Inspectional Observations

Posted in BioBusiness

US Food and Drug Administration (FDA) inspections of drug and devices manufacturing facilities are typically anxiety ridden exercises that can strike fear into even the most seasoned quality and regulatory affairs professionals. And, most manufacturing facilities do not escape these inspections unscathed and are routinely cited, in many cases, for minor infractions.

For those of you who may not be familiar with FDA inspections, manufacturing facilities that produce approved drugs and devices must be inspected every two years for insure regulatory compliance with Current Good Manufacturing Practices (CGMPs). During the inspection, FDA inspectors document “significant objectionable conditions, relating to products and/or processes or other violations of the Food Drug and Cosmetic Act” that they observe. These are known in the industry as Form FDA 483 Inspectional Observations or simply 483. Companies that receive 483s must correct the so-called objections conditions to remain CGMP compliant.

While receiving 483s during an inspection may be routine, it can be overwhelming to inexperienced companies and their representatives. With this in mind, I found a great blog post by Bruce McDuffee, Global Marketing Manager, Veriteq that provides insights on interacting with the agency to manage 483s. He offers the following advice:

“One thing that you should be clear about is that this is not a ‘warning letter’; it is an offer to help you resolve issues and improve your quality system. The FDA may or may not issue a warning letter next if you have not addressed the conditions of the 483 to its satisfaction. Receiving a 483 does not necessarily mean you are out of compliance.

In responding to a 483, your objectives should include these three things; establish credibility, demonstrate acknowledgement and understanding of the observations and the associated requirements and show commitment to corrective actions."

Bruce recommends that you take the following actions when dealing with 483s:

  1. Get your response in on time or even early if possible. The FDA wants to see the response within 15 days, so plan your review and internal processes accordingly.
  2. In the first paragraph, demonstrate your understanding of and desire to comply with FDA regulations.
  3. Respond individually to each item addressed on the form. Give a corrective action and time-frame for implementing.
  4. Prioritize by first addressing the conditions that will most likely affect product quality.
  5. Outline how and when each deficiency will be corrected.
  6. Avoid talking about whose fault the issue is or how it came to be. For example, keep a positive tone and indicate how the quality system will be improved.
  7. Include any reference documents, such as purchase agreements for a new monitoring system or employment agreement for a new quality manager.
  8. Keep in mind that there is a formal process available for you to dispute the findings.
  9. Be proactive in addressing the conditions. For example, address why the deficiencies were not detected internally and what will be done to correct this condition.
  10. Seek clarification with the inspector when you receive the 483 on the spot. Be sure you understand each objectionable condition before the inspector leaves the site. It may behoove you and your firm to seek out an industry expert if the matters seem complex or if the issues are not able to be resolved by your own personnel.”

While CGMP and regulatory compliance may seem like arcane concepts, they are vitally important and must be clearly understood by companies that are manufacturing FDA-approved drugs and devices. Failure to comply can result in penalties, monetary fines and revocation of a license to manufacture a drug or device.

Until next time….

Good Luck and Good Job Hunting (try regulatory affairs or quality assurance and control)

 

A New Role for Academic Scientists in New Drug Discovery and Development?

Posted in BioBusiness

There has been some buzz on LinkedIn and Facebook about an article that appeared in the March 3, 2011 issue of Nature Magazine. The article entitled “Traditional Drug-Discovery Model Ripe for Reform” and basically chronicles the decline in emphasis being placed by most companies on traditional in-house drug discovery as a source for new candidate molecules. Also, it points out that most big pharma companies now agree that they are not good at drug discovery but excel in clinical development and marketing of new medicines. Industry’s new view of itself is supported by the fact that over 200,000 pharmaceutical and biotechnology workers—roughly 50% were discovery scientists—have their lost jobs in the past three years or so. This begs the question “who is going to discover the new molecular entities that large drug companies are going clinically evaluate and ultimately market? According to the article, academic researchers are likely to play a pivotal role in this newly emerging drug discovery paradigm. 

The new model proposed in the article goes something like this. First, all intellectual property rights for certain compounds will be lifted or removed. Compounds of interest would subsequently be evaluated in small clinical trials for safety and possible efficacy. And, interested drug makers would only compete with one another on specific molecules after they were deemed safe and potentially effective. Up until this point, all data on prospective drug candidates would be openly published and freely available to interested parties.

Proponents of the model contend that the approach would allow drug targets to be more quickly validated and developed less expensively because there would less duplication of research activities. Further, it would reduce the exposure of patients to experimental molecules that have already deemed to be ineffective. Interestingly, the new model would rely exclusively on academic scientists who would be supported by a global initiative that cost about $325 million per years— with half coming from the pharmaceutical industry and half from the public. Finally, drug candidates identified in the initial screening process would be available to companies that participate in the initiative (presumably to the company that invested the most?)

While the proposed model is clearly “wishful thinking” on behalf of academics who are struggling to win grant support, it is deeply flaw and was obviously proposed by academic scientists who lack a clear understanding of the industrial drug development process. First, intellectual property (IP) and patents are the life blood of the industry and are in fact what allows drug companies to prevent competition in certain therapeutic areas maximize their return on investment on the drugs that they develop. Therefore, it is highly  unlikely that any drug maker would agree to lift or suspend IP around a novel new molecule. Second, must academic scientists are not qualified nor trained to engage in industrial drug development. Unlike academic science, industrial research is highly regulated and must be performed according the regulations and guidelines established by various regulatory agencies like the US Food and Drug Administration. If the research is not conducted in a regulatory compliant manner, then the prospective new drug will not be able to win regulatory approval. Third, eliminating IP would prevent university tech transfer offices—which exist almost entirely to manage a university’s IP—from negotiating lucrative licensing deals with interested companies or other parties. This, in turn, would reduce the contribution of funds by technology transfer offices that is used to run many academic research centers. Finally, the model is based upon the assumption that academic scientists (unlike drug companies) willfully and freely share information with one another for the “common good.” However, based on my experiences as an academic for over 20 years, most scientists don’t subscribe to the level of altruism and philanthropy attributed to them in the article. In fact the ego-involvement and competition amongst academics is so fierce, that  many academic refuse to share important new information or breakthroughs with their colleagues until grants are funded or the data are published in peer reviewed journals. Put simply, most academics are trained to work by themselves in their own laboratories and are neither interactive nor collaborative by nature.

There is no question that the old industrial drug discovery model is in transition and a new one will ultimately emerge. However, the role of academics in the new model is likely going to be less than proposed in present article. Too many systemic changes would be required for this model to be effective. That said, providing graduate students and postdocs with training in regulatory affairs and new drug development could be a step in the right direction! Nevertheless, a better solution to the problem may be a greater role for government in new drug discovery and development. To that end, the UK Medical Research Council has established the Developmental Pathway Funding Scheme that supports the development of promising basic science research into new drugs and medical devices. Also, Francis Collins, the current head of the National Institutes of Health has proposed the creation of a National Center for Advancing Translational Sciences to transform basic science into prospective new drugs and treatments.

Despite the good intentions of the article, the path forward for academic scientists is not going to be easy. To make matters worse, it is becoming increasingly difficult for PhD-trained scientists to find jobs. That said, if you are truly interested in industrial drug discovery and development I highly recommend that you take some regulatory affairs course or enroll in a certificate or MS degree program in biotechnology that teaches the business side of the life sciences industry.

Until next time…

Good Luck and Good Job Hunting!!!!!!!!!!

 

BioJobBlog Creates a New BioJobCenter Widget for Scientists, Regulatory Affairs and Quality Personnel and Other Bioprofessionals

Posted in BioJobBuzz

About a month ago, BioJobBlog in association with the JobJob Health Job Board launched the BioJobCenter; an automated job board designed to help persons looking for employment in the life sciences industry. While the site has been well received, we decided to create a widget for BioJobBlog that features the types of job openings that exist @ the BioJobCenter. The widget will allow readers to apply and search for jobs directly from the BioJobBlog website.

The widget is located in the upper left hand side of the BioJobBlog sidebar (in case you haven’t noticed). Job seekers who click on a job title are taken to the BioJobCenter where they can directly apply for the job (after you join the site). Refreshing the BioJobBlog page will display a new list of job openings! If you are looking for specific jobs in specific locations you can search for more jobs by surfing over to the BioJobCenter and conducting a formal job search there. 

In other news, JobJobHealth recently released an iPhone app that allows users to conduct job searches on their phones. The app (JobJobHealth) is available in the iTunes store!

Check it out!

Until next time…

Good Luck and Good Job Hunting!!!!!!!!!!!!

 

Considering a Career in Regulatory Affairs? A Fellowship at FDA Won't Hurt Your Chances

Posted in BioJobBuzz

As many of you already know, I talk to a lot of graduate students and postdoctoral fellows who are disillusioned with the prospect of remaining in the laboratory for the rest of their lives. Frequently, students mention regulatory affairs as an alternate career option and ask me what type of training and skills are required to transit into a regulatory career. Unfortunately, regulatory affairs is an industry specific career and regulatory affairs training programs with the possible exceptions of the courses offered by the Regulatory Affairs Professionals Society (RAPS) and the Drug Information Association (DIA) (which can be costly) are not readily accessible to graduate students and postdoctoral fellows. Consequently, I recommend that PhD-trained scientists who are interested in regulatory affairs check out employment opportunities at the US Food and Drug Administration (FDA). This is because there is no better place than FDA to learn the “ins and outs” of regulatory affairs!

Until recently, jobs, fellowships and training programs at the agency were scarce. However, while reading an industry trade magazine I came across an ad (posted below) announcing fellowship opportunities for PhD level life scientists, healthcare professionals, pharmacists and even engineers(although they only need a bachelors degree to be eligible.

This is an opportunity for those interested in a regulatory affairs career to give it a shot! For more info visiting the agency’s website

Until next time…

Good Luck and Good Job Hunting!!!!!!!!

SocialTwist Tell-a-Friend

 

Job Market For Bioscientists May Be Better Than Expected

Posted in BioJobBuzz

The US economy has lost about 7.1 million jobs since December 2007 and nationwide unemployment is hovering around 8.5 percent. Despite the lost of  about 80,000 pharmaceutical jobs over the past three years and unprecedented consolidation taking place in the life sciences sector—Merck-Schering Plough, Pfizer-Wyeth and Roche-Genentech—the job prospects for scientists at biotech companies, medical devices and diagnostics, and government appear to be stronger than anticipated. While drug discovery and sales jobs may be scare, there are rapidly emerging opportunities in the fields of medical communications, regulatory affairs, biomanufacturing, clinical trials management , bioengineering, medical devices/diagnostics and website development and management.

President Obama’s promise to restore science to its rightful place, his reversal of the ban on federal funding for embryonic stem cell research and an unwavering commitment to alternate energy technologies suggest that the future may be very bright for bioscientists. For example, there are massive hiring initiatives at federal agencies like the US Food and Drug Administration (FDA) and the Unites States Department of Agriculture (UDSA) — as the Obama administration attempts to overall these agencies— and funding levels at the National Institutes of Health are on the rise (aided in part by a $200 million Challenge Grant stimulus program).

While the road to economic recovery may be a long one, graduate students and postdoctoral fellows who are currently engaged in life sciences research should “stay the course and not jump ship just yet.” The life sciences industry is more recession proof than others and it will be one of the first to experience an economic turn around. And, when it does it is best to prepared to find a job!

Until next time…


Good Luck and Good Job Hunting!!!!!!

SocialTwist Tell-a-Friend

 

What You Ought to Know to Get a Job in the Pharmaceutical and Biotechnology Industries!

Posted in BioJobBuzz

Although industry and academia share a common bond (no pun intended), which is obviously science, the lexicons of these two seemingly similar but parallel worlds are markedly different. For example, do you know what the acronyms IND, NDA, cGMP, cGLP, BLA, CTD, PK or PD stand for? If you cannot decipher any of them, you ought to forget about getting a job in industry and stay in academia. If you know what 95 % or less of them mean, I highly recommend that you get some additional training before applying for your first industrial position. If you are one of the lucky few who recognized and correctly interpreted 100% of the acronyms, you are either working in industry or recently completed some postgraduate training in drug development and regulatory affairs. The point that I am trying to make is that you cannot possibly expect to get a job in industry if can’t speak the language that you need to know in order to succeed! As the old saying goes “You need to learn how to walk before you can run”.

So, take the test and your score will determine whether you are ready to apply for that long sought after job in the pharmaceutical or biotechnology industries.

Footnote: For those of you who are interested, you can decipher all of the acronyms that I listed by visiting and rooting around the FDA website.

Until next time….

Good Luck and Good Job Hunting!!!!!!!!!


Find information on Diversity recruiting at DiversityJobs.com.