Medical Affairs: A Growing Career Path

Drug development never rests. With new sophisticated molecules, medical devices, and even gene therapies, there is a higher demand for clinical and drug information, creating new career opportunities for pharmacists in the growing area of medical affairs.

Medical Affairs teams within pharmaceutical, biotech and medical device companies may be charged with the following:

• Relaying and providing clinical knowledge gained from trials to health care professionals and stakeholders.
• Managing relationships with key thought leaders and stakeholders.
• Developing clinical research protocols for investigational drugs or currently approved drugs in new indications.
• Developing health outcomes research for long-term data and return on investment for new molecules.

The jobs and functions that often occur within medical affairs include roles in publication planning, in-house medical information, and health outcomes researchers. Many companies also have field based medical science liaisons (MSLs) and economics liaisons.

Kyle Kennedy, vice president of Customer Strategy with the Medical Affairs Company (TMAC) and 28-year veteran of the pharmaceutical industry, sees big changes coming for medical affairs.

“The passage of the 21^st Century Cures Act will impact Medical Affairs. The bill would allow the FDA to rely more on short and simpler clinical trial designs when reviewing drugs for approval, and may eventually allow the FDA to rely more heavily on the use of surrogate endpoints such as biomarkers in the blood, versus harder outcomes data such as reduced death rates," Kennedy said. "In the medical device sector, the FDA could use smaller studies and real world evidence from company registries and other sources. These are additional opportunities for medical affairs professionals.”

William Soliman, PhD, BCMAS, Chair of the Accreditation Council for Medical Affairs, also sees changes in the health care landscape setting up huge opportunities for a career in medical affairs for pharmacists.

“With increased technology capabilities, ensuring seamless coordination between field based and internal medical affairs is becoming more important,” Dr. Soliman said. “Additionally, it is critical to ensure that medical affairs organizations are subject matter experts both internally and externally.”

All these changes support the need for more sophisticated and detailed clinical discussions with stakeholders in the health care industry for meaningful use of drugs. How, then, do pharmacists fit into medical affairs?

Roles within medical affairs are often filled by those with hard science PhDs, and healthcare professionals. In previous studies, 70% of MSLs had PharmDs, 10% had PhDs, and the rest were nurses or physicians.¹ Many internal medical information call centers are dominated by pharmacists.

With the increased cost of specialty drugs, along with appropriate use and novel mechanisms of action, the medical affairs teams at biopharmaceutical and medical device companies are growing, and expected to continue to grow in the next few years. Providers need more clinical and real-world outcomes to make sound clinical decisions for their patients, along with payers struggling to understand when appropriate therapy should be utilized when new therapies cost tens of thousands, if not hundreds of thousands of dollars per patient per course of therapy.

“Medical affairs has grown over 300% in the last decade and it will continue to do so,” Dr. Soliman stated. “Not only are physicians demanding more in depth information from highly trained clinical and scientific professionals, but our knowledge in medicine and science has grown exponentially, and with that comes an increased need for people who can deliver that information accurately and effectively.”

Dr. Soliman also emphasized the appeal of working in medical affairs, noting that it gives pharmacists the opportunity to work towards improving patient health on a larger scale.

“As a health care provider in a traditional setting, you're impacting patients’ lives on a case by case basis, which is great, but with medical affairs you're impacting patient lives at a macro level,” he said. “And because medical affairs has so many different functions, you will find many options available to you, depending on where your interests lie.”

Kennedy also sees medical affairs, and specifically the medical science liaison (MSL) role as a great career choice for pharmacists.

“I have always said that the MSL position is the best job in the pharmaceutical sector. You learn so many skills as an MSL that prepare you to be successful in other positions in the industry and successful in life," he explained. "Those skills include communication, decision making, leadership, teamwork, strategic thinking, and tenacity. In medical affairs, you have opportunities to work in or with clinical trial activities, medical information, competitive intelligence, pharmacovigilance, medical writing, health outcomes, scientific platform communications, and key opinion leader development, and you may even be able to move over to the commercial side of industry, such as marketing.”

For pharmacy students interested in pursuing a career in medical affairs, Dr. Soliman offered several suggestions.

“Medical affairs has grown dramatically, so there are many more career opportunities for pharmacists than ever, but it’s also a very competitive space; for each MSL opening there are about 200 applicants on average,” he explained. “So, if you want to get into medical affairs, you've got to distinguish yourself from your competition. Becoming board certified in medical affairs has become the standard, and I believe this will eventually become a requirement as regulatory and compliance standards become more stringent.”

In addition to becoming certified within medical affairs, a pharmacist with little medical affairs experience could network with other medical affairs professionals to learn more about the roles available inside at corporate headquarters for pharmacists, and/or field based medical affairs positions. Several organizations exist where you can meet professionals within medical affairs across the industry, such as the Drug Information Association.

Kennedy also emphasized the importance of building soft skills and business acumen.

“The most important soft skills include emotional quotient, assertiveness, business etiquette, business writing, change management, communication skills, conflict resolution, customer service and problem solving," he stated. "The pharmaceutical and biotech industries are big businesses, and it is critical that all employees understand that this is a for-profit industry; medical affairs is not exempt from that. You will need to understand strategy, operations, finance, supply chain, regulatory and even legal aspects of the industry."

There are significant opportunities for pharmacists within medical affairs. While some of the positions may not be for everyone, a career in medical affairs can provide many advantages amidst a shifting health care landscape. Explore, and enjoy the endless possibilities in this growing area of the industry.

Want to hear more about the field based medical science liaison (MSL) role? Listen to the Pharmacy Podcast on “What is a MSL?” also by Erin Albert at http://tinyurl.com/WhatIsAMSL.For more on the BCMAS certification in Medical Affairs, listen to the Pharmacy Podcast episode with guest Dr. Will Soliman at http://tinyurl.com/ACMABCMAS.

Erin Albert, MBA, PharmD, JD, PAHM, is a health outcomes pharmacist, Pharmacy Podcast Network co-host, writer, entrepreneur, attorney, preceptor, career coach, STEM advocate. She has written several books on careers in pharmacy, including The Life Science Lawyer and The New Pharmacist: 46 Doses of Advice. More on Dr. Albert can be found on her website, www.erinalbert.com.

Reference

• Albert, E., Sass C. The Medical Science Liaison: An A to Z Guide. http://mzn.to/2uvd1JA.